Home NDC 63629-3152 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Product NDC 63629-3152
11-digit product format 636293152
Labeler code 63629
Product ID 63629-3152_3f0c092b-08db-4e8f-136a-456e0e7bec14
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application NDA020232
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2003-09-18
Marketing end 0000-00-00
Substance CODEINE PHOSPHATE; BUTALBITAL; CAFFEINE; ACETAMINOPHEN
Active strength 30 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC],Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 104 matching rows.
View current auxiliary records. · View the auxiliary file history.
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.
Product history page 1 of 2 · 41 observed 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 2026-02-19 14:30 UTC 2026-02 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020232-001 FIORICET W/ CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1992-07-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-3152-1 2020-10-16 These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992 63629-3152-2 2020-10-16 These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992 63629-3152-3 2020-10-16 These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992 63629-3152-4 2020-10-16 These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992 63629-3152-5 2020-10-16 These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992 63629-3152-6 2020-10-16 These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992 63629-3152-7 2020-10-16 These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992 63629-3152-1 2020-01-31 These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992 63629-3152-2 2020-01-31 These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992 63629-3152-3 2020-01-31 These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992 63629-3152-4 2020-01-31 These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992 63629-3152-5 2020-01-31 These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992 63629-3152-6 2020-01-31 These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992 63629-3152-7 2020-01-31 These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992
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 [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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-3152-1 63629315201 20 CAPSULE in 1 BOTTLE (63629-3152-1) 20 capsule 2006-05-11 0000-00-00 No No Current 63629-3152-2 63629315202 90 CAPSULE in 1 BOTTLE (63629-3152-2) 90 capsule 2006-10-19 0000-00-00 No No Current 63629-3152-3 63629315203 30 CAPSULE in 1 BOTTLE (63629-3152-3) 30 capsule 2010-12-07 0000-00-00 No No Current 63629-3152-4 63629315204 60 CAPSULE in 1 BOTTLE (63629-3152-4) 60 capsule 2010-10-22 0000-00-00 No No Current 63629-3152-5 63629315205 100 CAPSULE in 1 BOTTLE (63629-3152-5) 100 capsule 2016-12-14 0000-00-00 No No Current 63629-3152-6 63629315206 15 CAPSULE in 1 BOTTLE (63629-3152-6) 15 capsule 2021-12-22 0000-00-00 No No Current 63629-3152-7 63629315207 18 CAPSULE in 1 BOTTLE (63629-3152-7) 18 capsule 2021-12-22 0000-00-00 No No Current