Home NDC 63629-5422-3 Hydrocodone Bitartrate and Acetaminophen
Product NDC 63629-5422
Requested package NDC 63629-5422-3
11-digit product format 636295422
Labeler code 63629
Product ID 63629-5422_1960bda9-b48f-4f7a-949a-b9fb8ab1ed67
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocodone Bitartrate and Acetaminophen
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA040736
Marketing category ANDA
Marketing start 2010-01-18
Substance ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength 325; 5 mg/1; mg/1
Pharmacologic classes Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule CII
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 1 · 13 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;5MG TABLET / ORAL AA 2006-08-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040736-001 AA
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 · 42 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 2026-08-18 06:07:40 2026-07 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040736-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2006-08-25 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Hydrocodone Bitartrate and Acetaminophen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCODONE BITARTRATE 5 mg/1 ACETAMINOPHEN 325 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination NO70W886KK Internal UNII lookup 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 857002 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-5422-1 2020-10-28 Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg) 63629-5422-2 2020-10-28 Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg) 63629-5422-3 2020-10-28 Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg) 63629-5422-4 2020-10-28 Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg) 63629-5422-5 2020-10-28 Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg) 63629-5422-6 2020-10-28 Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg) 63629-5422-7 2020-10-28 Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg) 63629-5422-8 2020-10-28 Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg) 63629-5422-9 2020-10-28 Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg) 63629-5422-1 2020-01-31 Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg) 63629-5422-2 2020-01-31 Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg) 63629-5422-3 2020-01-31 Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg) 63629-5422-4 2020-01-31 Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg) 63629-5422-5 2020-01-31 Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg) 63629-5422-6 2020-01-31 Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg) 63629-5422-7 2020-01-31 Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg) 63629-5422-8 2020-01-31 Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg) 63629-5422-9 2020-01-31 Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-5422-0 Hydrocodone Bitartrate and Acetaminophen 10 in 1 BOTTLE TABLET 10 1008 63629-5422-1 Hydrocodone Bitartrate and Acetaminophen 30 in 1 BOTTLE TABLET 30 1008 63629-5422-2 Hydrocodone Bitartrate and Acetaminophen 120 in 1 BOTTLE TABLET 120 1008 63629-5422-3 Hydrocodone Bitartrate and Acetaminophen 20 in 1 BOTTLE TABLET 20 1008 63629-5422-4 Hydrocodone Bitartrate and Acetaminophen 60 in 1 BOTTLE TABLET 60 1008 63629-5422-5 Hydrocodone Bitartrate and Acetaminophen 90 in 1 BOTTLE TABLET 90 1008 63629-5422-6 Hydrocodone Bitartrate and Acetaminophen 50 in 1 BOTTLE TABLET 50 1008 63629-5422-7 Hydrocodone Bitartrate and Acetaminophen 40 in 1 BOTTLE TABLET 40 1008 63629-5422-8 Hydrocodone Bitartrate and Acetaminophen 15 in 1 BOTTLE TABLET 15 1008 63629-5422-9 Hydrocodone Bitartrate and Acetaminophen 84 in 1 BOTTLE TABLET 84 1008
DailyMed Socrata Ingredients# 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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE AND ACETAMINOPHEN Amneal Pharmaceuticals of New York LLC 62be4147-6a72-49e5-9338-10887c65a93a 2025-10-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040736 application number: ANDA040736 Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE AND ACETAMINOPHEN AvPAK 5174bd9a-b777-a6e3-f72f-c16082ee67d3 2025-10-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040736 application number: ANDA040736 Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE AND ACETAMINOPHEN Bryant Ranch Prepack a200d099-fa55-4ef1-b8d7-936a7da1db00 2025-09-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040736 application number: ANDA040736 ndc (package): 63629-5422-3 ndc (product): 63629-5422 ndc11 (package): 63629542203 Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE AND ACETAMINOPHEN Proficient Rx LP 50be5d00-758e-4d01-8e78-40a60dbe67e5 2021-01-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040736 application number: ANDA040736
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 63629-5422-3 63629542203 20 TABLET in 1 BOTTLE (63629-5422-3) 20 tablet 2014-10-06 0000-00-00 No No Current