Home Applications 040099 Application 040099
Type ANDA
Sponsor APIL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NORCO ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET;ORAL 325MG;5MG No 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 A040099-001 NORCO ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;5MG TABLET / ORAL 1997-06-25
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 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040099-001 NORCO 325MG;5MG TABLET / ORAL AA RS 1997-06-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040099-001 NORCO 325MG;5MG TABLET / ORAL AA RS 1997-06-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040099-001 NORCO 325MG;5MG TABLET / ORAL AA RS 1997-06-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040099-001 NORCO 325MG;5MG TABLET / ORAL AA RS 1997-06-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040099-001 NORCO 325MG;5MG TABLET / ORAL AA RS 1997-06-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040099-001 NORCO 325MG;5MG TABLET / ORAL AA RS 1997-06-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040099-001 NORCO 325MG;5MG TABLET / ORAL AA RS 1997-06-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040099-001 NORCO 325MG;5MG TABLET / ORAL AA RS 1997-06-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040099-001 NORCO 325MG;5MG TABLET / ORAL 1997-06-25 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 Norco HYDROCODONE/APAP Direct_Rx ee248dfd-7aa7-7dcc-e053-2995a90af19f 2025-01-22 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Norco
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0023-6002 Norco Hydrocodone Bitartrate and Acetaminophen Allergan, Inc. ANDA Current 0023-6002 Norco Hydrocodone Bitartrate and Acetaminophen Allergan, Inc. ANDA Current 0023-6002 Norco Hydrocodone Bitartrate and Acetaminophen Allergan, Inc. ANDA Current 0023-6002 Norco Hydrocodone Bitartrate and Acetaminophen Allergan, Inc. ANDA Current 0023-6002 Norco Hydrocodone Bitartrate and Acetaminophen Allergan, Inc. ANDA Current 0904-6419 Hydrocodone Bitartate and Acetaminophen Hydrocodone Bitartate and Acetaminophen Major Pharmaceuticals ANDA Current 12634-264 HYDROCODONE BITARTRATE AND ACETAMINOPHEN hydrocodone bitartrate and acetaminophen Apotheca Inc. ANDA Current 54348-013 HYDROCODONE/APAP HYDROCODONE BITARTRATE, PharmPak, Inc. ANDA Current 68387-236 Norco Hydrocodone Bitartrate And Acetaminophen Keltman Pharmaceuticals Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 64646 SUPPL 2020-09-22 64645 SUPPL 2020-09-22 38867 SUPPL 2014-12-12 7572 SUPPL 2014-12-09 22083 SUPPL 2004-12-08