Home NDC 0591-3220-01 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Product NDC 0591-3220
Requested package NDC 0591-3220-01
11-digit product format 005913220
Labeler code 0591
Product ID 0591-3220_519e2ce9-e4af-4bd7-96fd-8bee4e3b4537
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Dosage form CAPSULE
Route ORAL
Labeler Actavis Pharma, Inc.
Application NDA020232
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2003-09-18
Substance ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Active strength 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [EPC], Xanthines [CS]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020232-001 FIORICET W/ CODEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020232-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N020232-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE Actavis Pharma, Inc. a58819b8-a52c-44a7-9ab0-c74480d98506 2026-01-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020232 application number: NDA020232 ndc (package): 0591-3220-01 ndc (product): 0591-3220 ndc11 (package): 00591322001
Additional Listing Data#
Finished product Yes
Brand name base Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CODEINE PHOSPHATE 325 mg/1 BUTALBITAL 50 mg/1 CAFFEINE 40 mg/1 ACETAMINOPHEN 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 993943 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0591-3220-01 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate 100 in 1 BOTTLE CAPSULE 100 38
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 21 BUTALBITAL ACTIVE INGREDIENT KHS0AZ4JVK BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 21 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 21 CODEINE PHOSPHATE ACTIVE INGREDIENT GSL05Y1MN6 BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 21 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 21 BUTALBITAL ACTIVE MOIETY KHS0AZ4JVK BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 21 CAFFEINE ACTIVE MOIETY 3G6A5W338E BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 21 CODEINE ANHYDROUS ACTIVE MOIETY UX6OWY2V7J BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 21 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 21 D&C RED NO. 7 INACTIVE INGREDIENT ECW0LZ41X8 BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 21 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 21 GELATIN INACTIVE INGREDIENT 2G86QN327L BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 21 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 21 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 21 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 21 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 21 ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE (CODEINE PHOSPHATE, BUTALBITAL, CAFFEINE, AND ACETAMINOPHEN CAPSULE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 BUTALBITAL ACTIVE INGREDIENT KHS0AZ4JVK BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE (CODEINE PHOSPHATE, BUTALBITAL, CAFFEINE, AND ACETAMINOPHEN CAPSULE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE (CODEINE PHOSPHATE, BUTALBITAL, CAFFEINE, AND ACETAMINOPHEN CAPSULE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 CODEINE PHOSPHATE ACTIVE INGREDIENT GSL05Y1MN6 BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE (CODEINE PHOSPHATE, BUTALBITAL, CAFFEINE, AND ACETAMINOPHEN CAPSULE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE (CODEINE PHOSPHATE, BUTALBITAL, CAFFEINE, AND ACETAMINOPHEN CAPSULE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 BUTALBITAL ACTIVE MOIETY KHS0AZ4JVK BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE (CODEINE PHOSPHATE, BUTALBITAL, CAFFEINE, AND ACETAMINOPHEN CAPSULE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 CAFFEINE ACTIVE MOIETY 3G6A5W338E BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE (CODEINE PHOSPHATE, BUTALBITAL, CAFFEINE, AND ACETAMINOPHEN CAPSULE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 CODEINE ACTIVE MOIETY Q830PW7520 BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE (CODEINE PHOSPHATE, BUTALBITAL, CAFFEINE, AND ACETAMINOPHEN CAPSULE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE (CODEINE PHOSPHATE, BUTALBITAL, CAFFEINE, AND ACETAMINOPHEN CAPSULE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 D&C RED NO. 7 INACTIVE INGREDIENT ECW0LZ41X8 BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE (CODEINE PHOSPHATE, BUTALBITAL, CAFFEINE, AND ACETAMINOPHEN CAPSULE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE (CODEINE PHOSPHATE, BUTALBITAL, CAFFEINE, AND ACETAMINOPHEN CAPSULE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE (CODEINE PHOSPHATE, BUTALBITAL, CAFFEINE, AND ACETAMINOPHEN CAPSULE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE (CODEINE PHOSPHATE, BUTALBITAL, CAFFEINE, AND ACETAMINOPHEN CAPSULE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE (CODEINE PHOSPHATE, BUTALBITAL, CAFFEINE, AND ACETAMINOPHEN CAPSULE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE (CODEINE PHOSPHATE, BUTALBITAL, CAFFEINE, AND ACETAMINOPHEN CAPSULE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE (CODEINE PHOSPHATE, BUTALBITAL, CAFFEINE, AND ACETAMINOPHEN CAPSULE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK] 2 BUTALBITAL ACTIVE INGREDIENT KHS0AZ4JVK BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK] 2 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK] 2 CODEINE PHOSPHATE ACTIVE INGREDIENT GSL05Y1MN6 BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK] 2 BUTALBITAL ACTIVE MOIETY KHS0AZ4JVK BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK] 2 CAFFEINE ACTIVE MOIETY 3G6A5W338E BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK] 2 CODEINE ANHYDROUS ACTIVE MOIETY UX6OWY2V7J BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK] 2 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK] 2 D&C RED NO. 7 INACTIVE INGREDIENT ECW0LZ41X8 BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-3220 BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 33 Current NDC, Legacy NDC, 1 package rows 20240412_a58819b8-a52c-44a7-9ab0-c74480d98506.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0591-3220-01 00591322001 100 CAPSULE in 1 BOTTLE (0591-3220-01) 100 capsule 2003-09-18 0000-00-00 No No Current