Ropivacaine Hydrochloride Injection (Naropin) shortage
Ropivacaine Hydrochloride Injection (brand name Naropin) is recorded by the U.S. Food and Drug Administration (FDA) with a shortage status of Current, covering 6 affected presentations across 2 strengths, first posted 2018-03-27 and last updated 2026-08-18. Inforlife SA is the single reporting company on this entry, filing 6 of the 6 source lines. The strengths listed are 2 mg/1 mL and 5 mg/1 mL. 6 package NDCs are referenced, under 1 FDA application number and 1 substance identifier. The FDA files it under Anesthesia. 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) | 2018-03-27 |
| Last updated | 2026-08-18 |
| Affected presentations | 6 |
| Strengths listed | 2 (2 mg/1 mL, 5 mg/1 mL) |
| Reporting manufacturers | 1 |
| Brand names | 1 (Naropin) |
| Generic name | Ropivacaine Hydrochloride Injection |
| Product form | Injection |
| Therapeutic category | Anesthesia |
| Package NDCs listed | 6 |
| openFDA source rows | 6 |
| Official source | https://www.accessdata.fda.gov/scripts/drugshortages/ |
Also known as
Ropivacaine Hydrochloride Injection is marketed under the brand name Naropin. 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 |
|---|---|---|---|
| Naropin | RxNorm (NLM) | RxCUI 134802 (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 6 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 |
|---|---|---|---|---|---|---|
| Inforlife SA | Ropivacaine Hydrochloride, Injection, 5 mg/1 mL (NDC 25021-652-82) | 5 mg/1 mL | 25021-652-82 | Current | Available | 2026-08-18 |
| Inforlife SA | Ropivacaine Hydrochloride, Injection, 2 mg/1 mL (NDC 25021-671-87) | 2 mg/1 mL | 25021-671-87 | Current | Available | 2026-08-18 |
| Inforlife SA | Ropivacaine Hydrochloride, Injection, 2 mg/1 mL (NDC 25021-671-66) | 2 mg/1 mL | 25021-671-66 | Current | Limited Availability | 2026-08-18 |
| Inforlife SA | Ropivacaine Hydrochloride, Injection, 2 mg/1 mL (NDC 25021-671-82) | 2 mg/1 mL | 25021-671-82 | Current | Available | 2026-08-18 |
| Inforlife SA | Ropivacaine Hydrochloride, Injection, 5 mg/1 mL (NDC 25021-652-87) | 5 mg/1 mL | 25021-652-87 | Current | Available | 2026-08-18 |
| Inforlife SA | Ropivacaine Hydrochloride, Injection, 2 mg/1 mL (NDC 25021-671-67) | 2 mg/1 mL | 25021-671-67 | Current | Unavailable | 2026-08-18 |
FDA application number(s) recorded against the affected products: ANDA206166. Substance identifier(s) (UNII): V910P86109.
Reporting manufacturers (1)
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 |
|---|---|---|---|---|
| Inforlife SA | 6 | 2 | 0 | 2 |
Reason recorded by the FDA
- 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
- Metronidazole Injection · Current · updated 2026-08-18 · 1 shared reporting company
Same FDA therapeutic category
- Dexmedetomidine Hydrochloride Injection · Current · updated 2026-08-20 · 1 shared category
- Etomidate Injection · Current · updated 2026-08-20 · 1 shared category
- Rocuronium Bromide Injection · Current · updated 2026-08-20 · 1 shared category
- Atropine Sulfate Injection · Current · updated 2026-08-18 · 1 shared category
- Bupivacaine Hydrochloride Injection · Current · updated 2026-08-18 · 1 shared category
- Lidocaine Hydrochloride Injection · Current · updated 2026-08-18 · 1 shared category
- Midazolam Hydrochloride Injection · Current · updated 2026-08-18 · 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 6 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 6 such lines rather than one page per line. The earliest initial posting date across them is 2018-03-27, and the latest update 2026-08-18. The FDA files this product under Anesthesia 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.
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 Ropivacaine Hydrochloride Injection, which is available in a presentation of 5 mg/1 mL. The product is marketed by Sagent Pharmaceuticals and is associated with Inforlife SA. The initial posting date of this record is March 27, 2018, and it was last updated on August 18, 2026. The product is currently available in the market.
Regulatory context
The status of 'Current' indicates that this product is actively marketed and compliant with FDA regulations. The availability field confirms that the product can be obtained in the market, while the initial posting and last updated dates provide a timeline of the record's maintenance and relevance.
The summary was derived from 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 Ropivacaine Hydrochloride Injection, which is available in a presentation of 2 mg/1 mL. The product is marketed by Sagent Pharmaceuticals and is associated with Inforlife SA. The initial posting date of this record is March 27, 2018, and it was last updated on August 18, 2026.
Regulatory context
The status of 'Current' indicates that this product is actively listed and available for use. The availability field confirms that the product can be obtained in the market, and the presence of an NDC number signifies its identification in the FDA database.
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 Ropivacaine Hydrochloride Injection, a pharmaceutical product presented as an injection with a concentration of 2 mg per 1 mL. The product is associated with the National Drug Code (NDC) 25021-671-66 and is marketed by Sagent Pharmaceuticals. The company responsible for this product is Inforlife SA. The status of the product is currently classified as 'Current', with limited availability noted. The initial posting date was March 27, 2018, and the last update was on August 18, 2026.
Regulatory context
The 'Current' status indicates that this product is actively recognized by the FDA and is available for use, while 'Limited Availability' suggests that there may be restrictions on its distribution or supply. The classification helps stakeholders understand the product's market presence and regulatory standing.
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 Ropivacaine Hydrochloride Injection, a pharmaceutical product available in a presentation of 2 mg/1 mL. The product is marketed by Sagent Pharmaceuticals and is manufactured by Inforlife SA. The initial posting date of this record is March 27, 2018, with the last update scheduled for August 18, 2026. The product is currently available in the market.
Regulatory context
The status 'Current' indicates that this product is actively listed and available for distribution. The availability field confirms that the product can be obtained in the market, and the provided NDC (National Drug Code) identifies the specific formulation and packaging of the product.
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 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 Ropivacaine Hydrochloride Injection, which is available in a presentation of 5 mg/1 mL. The product is marketed by Sagent Pharmaceuticals and is associated with the company Inforlife SA. The initial posting date of this record is March 27, 2018, and it was last updated on August 18, 2026.
Regulatory context
The status of 'Current' indicates that the product is actively marketed and available for use. The availability field confirms that the product can be obtained in the market, and the NDC number provides a unique identifier for the product in the FDA database.
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 Ropivacaine Hydrochloride Injection, which is presented as an injection formulation containing 2 mg of Ropivacaine Hydrochloride per 1 mL. The product is associated with Inforlife SA and is marketed by Sagent Pharmaceuticals. The status of this product is currently classified as 'Current', although it is noted as unavailable in the market. The initial posting date of this record is March 27, 2018, with the last update recorded on August 18, 2026.
Regulatory context
The 'Current' status indicates that the product is recognized and listed by the FDA, but its availability is marked as 'Unavailable', suggesting that it may not be accessible for purchase or distribution at this time. The classification helps in understanding the product's regulatory standing.
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.
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
- 2018-03-27
- Ingested
- 2026-08-22
- Record hash
10e0631d0dc61bab
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.