Lisdexamfetamine Dimesylate Capsule (Vyvanse) shortage
Lisdexamfetamine Dimesylate Capsule (brand name Vyvanse) is recorded by the U.S. Food and Drug Administration (FDA) with a shortage status of Current, covering 29 affected presentations across 7 strengths, first posted 2023-07-14 and last updated 2026-08-20. 6 companies report it — Alvogen, Elite Laboratories, Inc., Lannett Company, Inc., Mylan Pharmaceuticals Inc., A Viatris Company, Specgx LLC and Teva Pharmaceuticals Usa, Inc. — across 29 source lines. The strengths listed are 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg. 38 package NDCs are referenced, under 5 FDA application numbers and 1 substance identifier. The FDA files it under Psychiatry. Of the 1 brand name shown, 1 was verified against RxNorm and 0 came from the FDA record. Every line is reproduced below with its company, presentation, package NDC and the FDA's own availability text, so each can be checked individually. Confirm the live status at the official FDA shortage record before relying on it: this page is regulatory supply information only, it is not medical advice, it does not assess clinical impact, and it never suggests a substitute.
Regulatory snapshot
| FDA shortage status | Current |
|---|---|
| Since (first posted) | 2023-07-14 |
| Last updated | 2026-08-20 |
| Affected presentations | 29 |
| Strengths listed | 7 (10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg) |
| Reporting manufacturers | 6 |
| Brand names | 1 (Vyvanse) |
| Generic name | Lisdexamfetamine Dimesylate Capsule |
| Product form | Capsule |
| Therapeutic category | Psychiatry |
| Package NDCs listed | 38 |
| openFDA source rows | 29 |
| Official source | https://www.accessdata.fda.gov/scripts/drugshortages/ |
Also known as
Lisdexamfetamine Dimesylate Capsule is marketed under the brand name Vyvanse. Brand names are never inferred on this site: each one below carries the source that vouches for it, so a name published by the FDA and a name resolved from the U.S. National Library of Medicine's RxNorm vocabulary can always be told apart. RxNorm mappings are resolved at ingestion time from the RxNorm concept identifiers openFDA publishes on the shortage record itself, and are accepted only when the brand concept's ingredient set matches the source product's exactly.
| Brand name | Source | Concept identifier | Resolved |
|---|---|---|---|
| Vyvanse | RxNorm (NLM) | RxCUI 711043 (BN) | 2026-08-21 |
1 of 1 name(s) resolved through RxNorm; 0 taken from the FDA record itself.
Affected presentations, companies and availability
The FDA publishes one line per reported package presentation and reporting company. All 29 line(s) behind this entry are reproduced below — company, presentation, strength, package NDC, status, the agency's availability text verbatim, and the date each line was last updated — so any single line can be checked against the official record without leaving this page. No line becomes a page of its own.
| Reporting company | Presentation | Strength | Package NDC | Status | Availability (FDA text) | Updated |
|---|---|---|---|---|---|---|
| Mylan Pharmaceuticals Inc., A Viatris Company | Lisdexamfetamine Dimesylate, Capsule, 50 mg (NDC 0378-6858-77) | 50 mg | 0378-6858-77 | Current | Available | 2026-08-20 |
| Specgx LLC | Lisdexamfetamine Dimesylate, Capsule, 30 mg (NDC 0406-5113-01) | 30 mg | 0406-5113-01 | Current | Available | 2026-08-20 |
| Elite Laboratories, Inc. | Lisdexamfetamine Dimesylate, Capsule, 50 mg (NDC 64850-554-01) | 50 mg | 64850-554-01 | Current | Limited Availability | 2026-08-17 |
| Alvogen | Lisdexamfetamine Dimesylate, Capsule, 20 mg (NDC 47781-563-01) | 20 mg | 47781-563-01 | Current | Available | 2026-08-17 |
| Lannett Company, Inc. | Lisdexamfetamine Dimesylate, Capsule, 30 mg (NDC 0527-4663-37) | 30 mg | 0527-4663-37 | Current | Available | 2026-08-18 |
| Lannett Company, Inc. | Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 0527-4661-37) | 10 mg | 0527-4661-37 | Current | Available | 2026-08-18 |
| Lannett Company, Inc. | Lisdexamfetamine Dimesylate, Capsule, 40 mg (NDC 0527-4664-37) | 40 mg | 0527-4664-37 | Current | Available | 2026-08-18 |
| Teva Pharmaceuticals Usa, Inc. | Lisdexamfetamine Dimesylate, Capsule, 70 mg (NDC 0480-3564-01) | 70 mg | 0480-3564-01 | Current | Available | 2026-08-17 |
| Mylan Pharmaceuticals Inc., A Viatris Company | Lisdexamfetamine Dimesylate, Capsule, 30 mg (NDC 0378-6856-77) | 30 mg | 0378-6856-77 | Current | Available | 2026-08-20 |
| Specgx LLC | Lisdexamfetamine Dimesylate, Capsule, 50 mg (NDC 0406-5115-01) | 50 mg | 0406-5115-01 | Current | Available | 2026-08-20 |
| Elite Laboratories, Inc. | Lisdexamfetamine Dimesylate, Capsule, 40 mg (NDC 64850-553-01) | 40 mg | 64850-553-01 | Current | Limited Availability | 2026-08-17 |
| Teva Pharmaceuticals Usa, Inc. | Lisdexamfetamine Dimesylate, Capsule, 60 mg (NDC 0480-3570-01) | 60 mg | 0480-3570-01 | Current | Available | 2026-08-17 |
| Lannett Company, Inc. | Lisdexamfetamine Dimesylate, Capsule, 60 mg (NDC 0527-4666-37) | 60 mg | 0527-4666-37 | Current | Available | 2026-08-18 |
| Specgx LLC | Lisdexamfetamine Dimesylate, Capsule, 40 mg (NDC 0406-5114-01) | 40 mg | 0406-5114-01 | Current | Available | 2026-08-20 |
| Teva Pharmaceuticals Usa, Inc. | Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 0480-3565-01) | 10 mg | 0480-3565-01 | Current | Available | 2026-08-17 |
| Mylan Pharmaceuticals Inc., A Viatris Company | Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 0378-6854-77) | 10 mg | 0378-6854-77 | Current | Available | 2026-08-20 |
| Specgx LLC | Lisdexamfetamine Dimesylate, Capsule, 60 mg (NDC 0406-5116-01) | 60 mg | 0406-5116-01 | Current | Available | 2026-08-20 |
| Lannett Company, Inc. | Lisdexamfetamine Dimesylate, Capsule, 50 mg (NDC 0527-4665-37) | 50 mg | 0527-4665-37 | Current | Available | 2026-08-18 |
| Elite Laboratories, Inc. | Lisdexamfetamine Dimesylate, Capsule, 30 mg (NDC 64850-552-01) | 30 mg | 64850-552-01 | Current | Limited Availability | 2026-08-17 |
| Specgx LLC | Lisdexamfetamine Dimesylate, Capsule, 70 mg (NDC 0406-5117-01) | 70 mg | 0406-5117-01 | Current | Available | 2026-08-20 |
| Elite Laboratories, Inc. | Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 64850-550-01) | 10 mg | 64850-550-01 | Current | Limited Availability | 2026-08-17 |
| Specgx LLC | Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 0406-5111-01) | 10 mg | 0406-5111-01 | Current | Available | 2026-08-20 |
| Mylan Pharmaceuticals Inc., A Viatris Company | Lisdexamfetamine Dimesylate, Capsule, 40 mg (NDC 0378-6857-77) | 40 mg | 0378-6857-77 | Current | Available | 2026-08-20 |
| Specgx LLC | Lisdexamfetamine Dimesylate, Capsule, 20 mg (NDC 0406-5112-01) | 20 mg | 0406-5112-01 | Current | Available | 2026-08-20 |
| Lannett Company, Inc. | Lisdexamfetamine Dimesylate, Capsule, 20 mg (NDC 0527-4662-37) | 20 mg | 0527-4662-37 | Current | Available | 2026-08-18 |
| Mylan Pharmaceuticals Inc., A Viatris Company | Lisdexamfetamine Dimesylate, Capsule, 70 mg (NDC 0378-6860-77) | 70 mg | 0378-6860-77 | Current | Available | 2026-08-20 |
| Mylan Pharmaceuticals Inc., A Viatris Company | Lisdexamfetamine Dimesylate, Capsule, 20 mg (NDC 0378-6855-77) | 20 mg | 0378-6855-77 | Current | Available | 2026-08-20 |
| Lannett Company, Inc. | Lisdexamfetamine Dimesylate, Capsule, 70 mg (NDC 0527-4667-37) | 70 mg | 0527-4667-37 | Current | Available | 2026-08-18 |
| Mylan Pharmaceuticals Inc., A Viatris Company | Lisdexamfetamine Dimesylate, Capsule, 60 mg (NDC 0378-6859-77) | 60 mg | 0378-6859-77 | Current | Available | 2026-08-20 |
FDA application number(s) recorded against the affected products: ANDA202835, ANDA211840, ANDA214547, ANDA215802, ANDA218604. Substance identifier(s) (UNII): SJT761GEGS.
Reporting manufacturers (6)
Each company below filed at least one of the source lines above. The record counts shown are coverage-limited activity signals from the indexed datasets — never quality ratings.
| Company | Lines filed here | Indexed records | Recalls | Shortage entries |
|---|---|---|---|---|
| Alvogen | 1 | 3 | 0 | 2 |
| Elite Laboratories, Inc. | 4 | 2 | 0 | 2 |
| Lannett Company, Inc. | 7 | 6 | 3 | 3 |
| Mylan Pharmaceuticals Inc., A Viatris Company | 7 | 1 | 0 | 1 |
| Specgx LLC | 7 | 5 | 0 | 2 |
| Teva Pharmaceuticals Usa, Inc. | 3 | 8 | 1 | 7 |
Reason recorded by the FDA
- Shortage of an active ingredient
Reproduced verbatim from the FDA's shortage record as a regulatory data field — not restated, summarised or interpreted here.
Related shortages
Every link below comes from a relation in the FDA data itself — a shared substance identifier, a shared reporting company, or a shared FDA therapeutic category — ordered by the strength of that overlap. Nothing here is a popularity list or an editorial suggestion.
Same active substance
- Lisdexamfetamine Dimesylate Tablet, Chewable · Current · updated 2026-08-17 · 1 shared substance identifier
Reported by the same companies
- Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet · Current · updated 2026-08-20 · 5 shared reporting companies
- Methylphenidate Hydrochloride Tablet, Extended Release · Current · updated 2026-08-19 · 2 shared reporting companies
- Carboplatin Injection · Current · updated 2026-08-18 · 1 shared reporting company
- Clonazepam Tablet · Current · updated 2026-08-17 · 1 shared reporting company
- Hydromorphone Hydrochloride Injection · Current · updated 2026-08-17 · 1 shared reporting company
- Methotrexate Sodium Injection · Current · updated 2026-08-17 · 1 shared reporting company
How to interpret this shortage record
A drug-shortage entry means the FDA has logged a reported supply constraint for a product as part of its public shortage tracking. The status (Current) describes where the shortage sits in its lifecycle according to the agency's data. Because the FDA publishes one line per reported package and reporting company, this page consolidates 29 such lines into the single shortage they describe; each line remains listed below with its own company, presentation and availability text so it can be checked individually against the source. A shortage entry is an administrative supply signal — it does not describe the clinical role of the product, does not suggest any substitute, and does not indicate that any specific patient is affected. Read this entry as a pointer to the official FDA shortage listing and confirm the live status there before relying on it.
What an FDA shortage entry is
A drug-shortage entry of this kind is an administrative supply-status record that the FDA maintains and publishes for transparency and reference. It names the affected product, attributes the report to the companies shown above, and records a status marking where the shortage sits within the agency's public tracking lifecycle at the time it was ingested by this site. The FDA publishes one line per reported package presentation and reporting company, so this entry is assembled from 29 such lines rather than one page per line. The earliest initial posting date across them is 2023-07-14, and the latest update 2026-08-20. The FDA files this product under Psychiatry in its own therapeutic categorisation, which is reproduced here as a source field and carries no clinical meaning on this page. All values shown here are reproduced as regulatory data points from the official FDA drug-shortages dataset to help you find and verify the original entry. This page does not advise on therapeutic substitution, does not assess clinical impact, and is not a recommendation of any kind.
Why this page has one address
This page's address is derived from the shortage's own identity — the product name as the FDA publishes it, including the form in which it is supplied — and not from the entry's status, from the reporting company, or from the order in which the openFDA API happened to return its rows. That means the address stays the same when the status changes from current to resolved, when another company is added to the same shortage, or when a further package presentation is reported. Distinct product forms of the same molecule — an injection and an oral capsule, say — remain distinct pages, because the FDA tracks them as separate shortages. 44 earlier addresses for this entry redirect here permanently, so previously published links continue to resolve.
What this record does not mean
This shortage record does not constitute medical advice and does not tell you whether to start, stop, switch, or avoid any product. It does not assess safety for any individual, does not provide dosage, treatment, or therapeutic guidance, and does not diagnose any condition. The dataset is coverage-limited: it reflects what the FDA has published in the indexed source at ingestion time, which may lag the live record and may omit details held only in primary documents. For any health decision, consult a qualified healthcare professional, and for the authoritative record consult the FDA directly through the linked official source.
Source-row notes
Source-derived regulatory summary
The text in this section is generated from the FDA source fields shown elsewhere on this page. It is regulatory information only — not medical advice — and adds no facts beyond the official record.
This record pertains to Lisdexamfetamine Dimesylate Capsule, a medication presented in a 50 mg capsule form. It is currently available and is associated with the company Mylan Pharmaceuticals Inc., A Viatris Company. The record includes details such as the National Drug Code (NDC 0378-6858-77) and indicates its relevance to the field of psychiatry. The initial posting date was July 14, 2023, with the last update scheduled for August 20, 2026.
Regulatory context
The status 'Current' indicates that this product is actively available in the market. The classification as 'Available' signifies that it can be obtained by consumers or healthcare providers. The dates provided reflect the timeline of the record's posting and updates, which are important for tracking regulatory compliance and product availability.
Fields used include generic_name, status, presentation, availability, company_name, related_info, initial_posting_date, and last_updated_date. No fields were absent.
Source-derived regulatory summary
The text in this section is generated from the FDA source fields shown elsewhere on this page. It is regulatory information only — not medical advice — and adds no facts beyond the official record.
This record pertains to Lisdexamfetamine Dimesylate Capsule, a medication presented in a 50 mg capsule form. The National Drug Code (NDC) is 0406-5115-01. It is currently available and is associated with the field of psychiatry. The initial posting date of this record is July 14, 2023, with the last update scheduled for August 20, 2026. The manufacturer of this product is Specgx LLC.
Regulatory context
The status 'Current' indicates that this product is actively marketed and available for use. The classification as 'Available' signifies that it can be obtained by consumers or healthcare providers. The dates provided reflect the timeline of the record's posting and updates, which are important for tracking regulatory compliance.
Fields used include generic_name, status, presentation, availability, company_name, related_info, initial_posting_date, and last_updated_date. No fields were absent.
Source-derived regulatory summary
The text in this section is generated from the FDA source fields shown elsewhere on this page. It is regulatory information only — not medical advice — and adds no facts beyond the official record.
This record pertains to Lisdexamfetamine Dimesylate Capsule, a medication presented in a 10 mg capsule form. It is currently available and is associated with the company Mylan Pharmaceuticals Inc., A Viatris Company. The record includes information about its initial posting date and last updated date, indicating ongoing regulatory oversight. The related information suggests its use in the field of psychiatry.
Regulatory context
The status 'Current' indicates that this product is actively monitored and available for use. The availability field confirms that the product can be obtained in the market. The initial posting and last updated dates reflect the timeline of regulatory documentation and updates.
The summary was derived from fields including generic_name, status, presentation, availability, company_name, related_info, initial_posting_date, and last_updated_date. No fields were omitted.
Source-derived regulatory summary
The text in this section is generated from the FDA source fields shown elsewhere on this page. It is regulatory information only — not medical advice — and adds no facts beyond the official record.
This record pertains to Lisdexamfetamine Dimesylate Capsule, a medication presented in a 60 mg capsule form, identified by NDC 0406-5116-01. The product is currently available and is associated with the field of psychiatry. The record was initially posted on July 14, 2023, and the last update was made on August 20, 2026. It is produced by Specgx LLC.
Regulatory context
The status 'Current' indicates that the product is actively available in the market. The classification as 'Available' signifies that it can be obtained by consumers or healthcare providers. The dates provided reflect the timeline of the record's posting and updates, which are relevant for tracking regulatory compliance and product information.
The summary is based on the fields: generic_name, status, presentation, availability, company_name, related_info, initial_posting_date, and last_updated_date. No fields were omitted.
Source-derived regulatory summary
The text in this section is generated from the FDA source fields shown elsewhere on this page. It is regulatory information only — not medical advice — and adds no facts beyond the official record.
This record pertains to Lisdexamfetamine Dimesylate Capsule, which is a medication presented in a 60 mg capsule form. It is currently available and is associated with the company Mylan Pharmaceuticals Inc., A Viatris Company. The record includes details such as the National Drug Code (NDC 0378-6859-77) and indicates its relevance to the field of psychiatry. The initial posting date is July 14, 2023, with the last update scheduled for August 20, 2026.
Regulatory context
The status 'Current' indicates that this product is actively marketed and available for use. The classification under 'availability' confirms that it can be obtained by consumers. The record is part of regulatory information and does not imply any medical advice or endorsement.
Fields used include generic_name, status, presentation, availability, company_name, related_info, initial_posting_date, and last_updated_date. No fields were absent.
How to read this data
Where to go next
- All indexed FDA drug shortages — the full shortage hub with status counts.
- Current FDA drug shortages — every entry with an active status.
- Manufacturer regulatory signals — recall and shortage activity by firm.
- FDA drug recalls — the enforcement-report side of the same datasets.
- Regulatory guides — how these records work and how to verify them.
- Methodology and FDA data sources — how this entry was built.
- Glossary and dataset freshness — definitions and currency.
Source & provenance
- Official source
- https://www.accessdata.fda.gov/scripts/drugshortages/
- Source dataset
- openFDA Drug Shortages API
- Publication date
- 2023-07-14
- Ingested
- 2026-08-22
- Record hash
3ae67fc841b383b5
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.