Hydrocodone Bitartrate · Regulatory label update

FDA supplemental approval: Hydrocodone Bitartrate AND Ibuprofen (REMS)

U.S. Food and Drug Administration · June 18, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA approved a supplemental application (REMS) for hydrocodone bitartrate 5 mg combined with ibuprofen 200 mg tablets on 18 June 2026. This record documents a regulatory action and risk management strategy modification; it does not contain or report clinical trial evidence, efficacy data, or safety outcomes.

What was studied

Regulatory label update.

Key findings

Supplemental REMS approval granted for hydrocodone bitartrate 5 mg and ibuprofen 200 mg oral tablet formulation

Safety

This record does not contain clinical trial results, efficacy data, safety outcomes, or comparative evidence.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA supplemental approval for a REMS (Risk Evaluation and Mitigation Strategy) modification to an existing hydrocodone-ibuprofen combination product; this is a regulatory action, not a clinical evidence report.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-18

Hydrocodone bitartrate dose5 mg

Ibuprofen dose200 mg

Caveats

This record does not contain clinical trial results, efficacy data, safety outcomes, or comparative evidence.
The nature of the REMS modification and its specific requirements are not detailed in this approval record.
No sample size, statistical analysis, or outcome measures are reported.
Regulatory approval does not constitute evidence of clinical efficacy or superiority over comparators.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

This is a regulatory action record, not a clinical study.

Directness

insufficient

Regulatory approval does not report clinical trial outcomes or comparators.

Consistency

insufficient

No clinical data or comparative evidence is presented in this record.

Risk of bias

insufficient

Risk of bias assessment does not apply to regulatory action records.

Sample adequacy

insufficient

No clinical trial sample is described in this regulatory record.

Source abstract

Drugs@FDA record for application ANDA077454. This is a regulatory action record, not a clinical study. Brand name: HYDROCODONE BITARTRATE AND IBUPROFEN. Active ingredient: HYDROCODONE BITARTRATE. Sponsor: ANI PHARMS. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: HYDROCODONE BITARTRATE AND IBUPROFEN, TABLET, ORAL, HYDROCODONE BITARTRATE 5MG + IBUPROFEN 200MG.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Hydrocodone BitartrateANI Pharms