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 application for a Risk Evaluation and Mitigation Strategy (REMS) governing hydrocodone bitartrate 5 mg + acetaminophen 325 mg tablets on 18 June 2026. This is a regulatory authorization document, not a clinical trial report, and does not contain efficacy, safety, or comparative outcome data.

What was studied

Regulatory label update. Intervention: Hydrocodone bitartrate 5 mg + acetaminophen 325 mg, tablet, oral formulation.

Key findings

Supplemental REMS approval for hydrocodone bitartrate 5 mg + acetaminophen 325 mg oral tablets (Strides Pharma International, ANDA 040655)

Safety

This is a regulatory action record, not a clinical trial; no efficacy, safety, or comparative outcome data are reported. No information on prior approvals, adverse event history, or clinical justification for the REMS is provided.

Who this may help

This record documents regulatory authorization of a REMS for an existing opioid–acetaminophen product; it does not present clinical evidence and should not be interpreted as a statement of efficacy, safety comparison, or clinical benefit. Clinicians should consult the approved REMS protocol and product labeling for prescribing requirements.

Plain-language summary

FDA supplemental approval for a Risk Evaluation and Mitigation Strategy (REMS) governing an existing opioid–acetaminophen combination; documents regulatory action, not clinical evidence of efficacy or safety.

Study design

As stated by the source record.

InterventionHydrocodone bitartrate 5 mg + acetaminophen 325 mg, tablet, oral formulation

Reported figures

Quoted from the source exactly as published.

Approval status date2026-06-18

Hydrocodone bitartrate dose5 mg

Acetaminophen dose325 mg

Clinical bottom line

Caveats

This is a regulatory action record, not a clinical trial; no efficacy, safety, or comparative outcome data are reported.
REMS content and rationale are not detailed in this record.
No information on prior approvals, adverse event history, or clinical justification for the REMS is provided.
The record does not describe the population intended to use the product or any restrictions on distribution.

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 approval record; no clinical trial design described.

Directness

insufficient

Record documents approval action only; does not report clinical outcomes or comparative benefit.

Consistency

insufficient

No clinical data or evidence synthesis presented in this regulatory record.

Risk of bias

insufficient

Not applicable to a regulatory submission document; no trial methodology disclosed.

Sample adequacy

insufficient

No patient population or sample size described in approval record.

Source abstract

Drugs@FDA record for application ANDA040655. This is a regulatory action record, not a clinical study. Brand name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN. Active ingredient: ACETAMINOPHEN. Sponsor: STRIDES PHARMA INTL. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: HYDROCODONE BITARTRATE AND ACETAMINOPHEN, TABLET, ORAL, ACETAMINOPHEN 325MG + HYDROCODONE BITARTRATE 5MG.

Follow from this

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

AcetaminophenStrides Pharma Intl