Methylphenidate Hydrochloride Tablet, Extended Release (Relexxii) shortage

Also known as

Methylphenidate Hydrochloride Tablet, Extended Release is marketed under the brand names Concerta, Relexxii. 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.

2 of 2 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 23 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.

FDA application number(s) recorded against the affected products: ANDA076655, ANDA076772, ANDA091695, ANDA205327, NDA021121, NDA216117. Substance identifier(s) (UNII): 4B3SC438HI.

Reporting manufacturers (5)

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.

Reason recorded by the FDA

• Demand increase for the drug
• Other

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.

Reported by the same companies

• Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet · Current · updated 2026-08-20 · 2 shared reporting companies
• Lisdexamfetamine Dimesylate Capsule · Current · updated 2026-08-20 · 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

Same FDA therapeutic category

• Lisdexamfetamine Dimesylate Tablet, Chewable · Current · updated 2026-08-17 · 1 shared category

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 23 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 23 such lines rather than one page per line. The earliest initial posting date across them is 2023-07-26, and the latest update 2026-08-19. 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. 21 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.

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.