Home NDC 60429-591 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product NDC 60429-591
11-digit product format 604290591
Labeler code 60429
Product ID 60429-591_28f3a26a-dadc-492c-e063-6294a90a817f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage form TABLET
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA040405
Marketing category ANDA
Marketing start 2000-09-08
Marketing end 2026-06-30
Substance ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength 325; 7.5 mg/1; mg/1
Pharmacologic classes Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule CII
NDC exclude flag No
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
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 A040405-001 ANEXSIA 7.5/325 ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040405-001 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 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA 2000-09-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA 2000-09-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA 2000-09-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA 2000-09-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA 2000-09-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA 2000-09-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA 2000-09-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA 2000-09-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60429-591-01 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 100 in 1 BOTTLE TABLET 100 12 60429-591-05 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 500 in 1 BOTTLE TABLET 500 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60429-591 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 12 Current NDC, Legacy NDC, 2 package rows 20241213_87ed3420-1697-6f42-e053-2995a90a1a5b.zip
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 · 3 matching rows.
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 60429-591-01 60429059101 100 TABLET in 1 BOTTLE (60429-591-01) 100 tablet 2019-05-09 2026-06-30 No No Current 60429-591-05 60429059105 500 TABLET in 1 BOTTLE (60429-591-05) 500 tablet 2019-05-09 0000-00-00 No No Current