Home NDC 45865-407 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product NDC 45865-407
11-digit product format 458650407
Labeler code 45865
Product ID 45865-407_feab4bc9-ea2d-41fe-bf5e-99c2897df8b6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage form TABLET
Route ORAL
Labeler Medsource Pharmaceuticals
Application ANDA089160
Marketing category ANDA
Marketing start 2010-04-22
Marketing end 0000-00-00
Substance HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength 5 mg/1; mg/1
Pharmacologic classes Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule CIII
NDC exclude flag E
Listing certified through 2017-12-31
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 4 · 220 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A089160-001 ANEXSIA ACETAMINOPHEN; HYDROCODONE BITARTRATE 500MG;5MG TABLET / ORAL 1987-04-23
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 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089160-001 ANEXSIA 500MG;5MG TABLET / ORAL 1987-04-23 e64feba35796…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 45865-407-06 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 6 in 1 BOTTLE TABLET 6 1 45865-407-15 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 15 in 1 BOTTLE TABLET 15 1 45865-407-20 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 20 in 1 BOTTLE TABLET 20 1 45865-407-30 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 30 in 1 BOTTLE TABLET 30 1 45865-407-49 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 100 in 1 BOTTLE TABLET 100 1 45865-407-51 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 120 in 1 BOTTLE TABLET 120 1 45865-407-57 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 180 in 1 BOTTLE TABLET 180 1 45865-407-60 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 60 in 1 BOTTLE TABLET 60 1 45865-407-90 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 90 in 1 BOTTLE TABLET 90 1
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45865-407 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS] 1 Legacy NDC, 9 package rows 20120725_77e4446e-78a0-4596-9679-15938eb0f892.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 45865-407-06 45865040706 6 in 1 BOTTLE Historical 45865-407-15 45865040715 15 in 1 BOTTLE Historical 45865-407-20 45865040720 20 in 1 BOTTLE Historical 45865-407-30 45865040730 30 in 1 BOTTLE Historical 45865-407-49 45865040749 100 in 1 BOTTLE Historical 45865-407-51 45865040751 120 in 1 BOTTLE Historical 45865-407-57 45865040757 180 in 1 BOTTLE Historical 45865-407-60 45865040760 60 in 1 BOTTLE Historical 45865-407-90 45865040790 90 in 1 BOTTLE Historical