Home Applications 020232 Application 020232
Type NDA
Sponsor ACTAVIS LABS UT INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FIORICET W/ CODEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE;ORAL 325MG;50MG;40MG;30MG Yes 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.
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.
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 ndc (product): 0591-3220
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0591-3220 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Actavis Pharma, Inc. NDA AUTHORIZED GENERIC Current 0591-3220 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Actavis Pharma, Inc. NDA AUTHORIZED GENERIC Current 0591-3220 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Actavis Pharma, Inc. NDA AUTHORIZED GENERIC Current 0591-3220 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Actavis Pharma, Inc. NDA AUTHORIZED GENERIC Current 0591-3220 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Actavis Pharma, Inc. NDA AUTHORIZED GENERIC Current 63629-3152 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 63629-3152 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 63629-3152 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current