Fioricet W/ Codeine

Manages symptom complex of tension (or muscle contraction) headache. NDA 20232, held by Actavis Labs Ut Inc. Acetaminophen; Butalbital; Caffeine; Codeine Phosphate.

As of Nov 14, 2026, NDA 20232 (Fioricet W/ Codeine), held by Actavis Labs Ut Inc, was first approved by FDA on Jul 30, 1992, with 29 approved supplements and 0 published complete response letters.

First approved: Jul 30, 1992
Review: Standard
Supplements approved: 29
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy,, reserve opioid analgesics, including Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 30 submissions below

Date	Submission	Status	Documents
Jul 30, 1992	Original applicationNew formulation or manufacturer · Standard review	Approved	REMS

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fioricet W/ Codeine325MG;50MG;40MG;30MG · capsule;oral	Acetaminophen; Butalbital; Caffeine; Codeine Phosphate	RxReference drug

All 30 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 53REMS	Approved	Letter
Dec 22, 2025	Supplement 52Labeling · Standard review	Approved	Label Letter
Oct 31, 2024	Supplement 48REMS	Approved	Letter
Dec 15, 2023	Supplement 47Labeling · Standard review	Approved	Letter Label Medication Guide
Mar 4, 2021	Supplement 45Labeling · Standard review	Approved	Label Medication Guide Letter
Oct 7, 2019	Supplement 44Labeling · Standard review	Approved	Label Medication Guide Letter
Sep 18, 2018	Supplement 43Labeling · Standard review	Approved	Label Letter
Sep 18, 2018	Supplement 42REMS	Approved	Label Letter
Aug 29, 2017	Supplement 41Labeling · Standard review	Approved	Label Letter
Dec 16, 2016	Supplement 40Labeling · Standard review	Approved	Label Letter
Jul 31, 2015	Supplement 39Manufacturing · Standard review	Approved	None posted
Jun 16, 2015	Supplement 38Manufacturing · Standard review	Approved	None posted
Jun 5, 2014	Supplement 37Manufacturing · Standard review	Approved	None posted
Oct 18, 2013	Supplement 36Labeling · Standard review	Approved	Letter Label
May 9, 2013	Supplement 35Labeling	Approved	Label Letter
Jun 22, 2011	Supplement 33Labeling	Approved	Label Letter
Mar 21, 2008	Supplement 21Labeling · Standard review	Approved	Letter Label
Apr 26, 2002	Supplement 16Manufacturing · Standard review	Approved	None posted
Jan 3, 2002	Supplement 15Manufacturing · Standard review	Approved	None posted
Oct 4, 2001	Supplement 12Labeling · Standard review	Approved	None posted
May 30, 2001	Supplement 13Manufacturing · Standard review	Approved	None posted
May 22, 2001	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 3, 1999	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 22, 1999	Supplement 9Manufacturing · Standard review	Approved	None posted
May 20, 1998	Supplement 8Labeling · Standard review	Approved	None posted
Jan 18, 1996	Supplement 4Labeling · Standard review	Approved	None posted
Nov 8, 1995	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 29, 1994	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 1, 1992	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 30, 1992	Original applicationNew formulation or manufacturer · Standard review	Approved	REMS

Identifiers

Application: NDA 20232
Drugs@FDA: Overview at FDA
Company: Actavis Laboratories UT

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters