Hydrocodone Bitartrate AND Acetaminophen · Regulatory label update

FDA supplemental approval: Hydrocodone Bitartrate AND Acetaminophen (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 REMS application for three strengths of hydrocodone bitartrate–acetaminophen tablets (5 mg, 7.5 mg, and 10 mg hydrocodone with 325 mg acetaminophen) manufactured by AuroLife Pharma LLC, effective 18 June 2026. This record documents regulatory action only and does not contain clinical trial results, efficacy data, or safety comparisons.

What was studied

Regulatory label update.

Key findings

Supplemental REMS approval for hydrocodone bitartrate–acetaminophen combination tablet in three strengths: 5 mg, 7.5 mg, and 10 mg hydrocodone with 325 mg acetaminophen each Approval granted 18 June 2026 by FDA under application ANDA201013 (Abbreviated New Drug Application)

Safety

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

Who this may help

This is a regulatory notification of REMS approval only. It confirms that the manufacturer may distribute these formulations under specified risk mitigation requirements, but does not provide clinical evidence of efficacy, safety, or comparative benefit. Clinicians should refer to the prescribing information and REMS program details for guidance on appropriate use.

Plain-language summary

FDA supplemental approval of a REMS (Risk Evaluation and Mitigation Strategy) for an existing hydrocodone-acetaminophen combination, affecting distribution and prescribing requirements for opioid-containing pain medication.

Reported figures

Quoted from the source exactly as published.

Hydrocodone strength 15 mg

Hydrocodone strength 27.5 mg

Hydrocodone strength 310 mg

Acetaminophen dose (all strengths)325 mg

Approval date2026-06-18

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy data, safety outcomes, or comparative effectiveness information.
The specific requirements and restrictions of the REMS program are not detailed in this record.
No patient population, sample size, or outcome data are reported.
This is an approval action for an ANDA (generic or authorized equivalent), not a new drug application with clinical evidence.

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

Regulatory action record; no clinical study design reported.

Directness

insufficient

Record does not report clinical outcomes or comparative efficacy.

Consistency

insufficient

No trial data or comparative evidence presented in this regulatory record.

Risk of bias

insufficient

Regulatory action; bias assessment framework does not apply.

Sample adequacy

insufficient

Regulatory record; no patient population or sample size reported.

Source abstract

Drugs@FDA record for application ANDA201013. This is a regulatory action record, not a clinical study. Brand name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN. Active ingredient: HYDROCODONE BITARTRATE AND ACETAMINOPHEN. Sponsor: AUROLIFE PHARMA LLC. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: HYDROCODONE BITARTRATE AND ACETAMINOPHEN, TABLET, ORAL, ACETAMINOPHEN 325MG + HYDROCODONE BITARTRATE 10MG; HYDROCODONE BITARTRATE AND ACETAMINOPHEN, TABLET, ORAL, ACETAMINOPHEN 325MG + HYDROCODONE BITARTRATE 5MG; HYDROCODONE BITARTRATE AND ACETAMINOPHEN, TABLET, ORAL, ACETAMINOPHEN 325MG + HYDROCODONE BITARTRATE 7.5MG.

Follow from this

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

Hydrocodone Bitartrate AND AcetaminophenAurolife Pharma