Application 040148
- Type
- ANDA
- Sponsor
- APIL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NORCO | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;10MG | No | Yes |
| 002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 500MG;10MG | No | No |
| 003 | NORCO | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;7.5MG | No | Yes |
| 004 | NORCO | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;2.5MG | No | No |
| 005 | NORCO | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040148-001 | NORCO | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET / ORAL | 1997-02-14 | ||
| A040148-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 500MG;10MG | TABLET / ORAL | 1997-02-14 | ||
| A040148-003 | NORCO | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET / ORAL | 2000-09-12 | ||
| A040148-004 | NORCO | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;2.5MG | TABLET / ORAL | 2014-07-07 | ||
| A040148-005 | NORCO | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;5MG | TABLET / ORAL | 2014-07-07 |
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.
| 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 | A040148-001 | NORCO | 325MG;10MG | TABLET / ORAL | 1997-02-14 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040148-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;10MG | TABLET / ORAL | 1997-02-14 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040148-003 | NORCO | 325MG;7.5MG | TABLET / ORAL | 2000-09-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040148-004 | NORCO | 325MG;2.5MG | TABLET / ORAL | 2014-07-07 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040148-005 | NORCO | 325MG;5MG | TABLET / ORAL | 2014-07-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040148-001 | NORCO | 325MG;10MG | TABLET / ORAL | 1997-02-14 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040148-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;10MG | TABLET / ORAL | 1997-02-14 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040148-003 | NORCO | 325MG;7.5MG | TABLET / ORAL | 2000-09-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040148-004 | NORCO | 325MG;2.5MG | TABLET / ORAL | 2014-07-07 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040148-005 | NORCO | 325MG;5MG | TABLET / ORAL | 2014-07-07 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040148-001 | NORCO | 325MG;10MG | TABLET / ORAL | 1997-02-14 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040148-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;10MG | TABLET / ORAL | 1997-02-14 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040148-003 | NORCO | 325MG;7.5MG | TABLET / ORAL | 2000-09-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040148-004 | NORCO | 325MG;2.5MG | TABLET / ORAL | 2014-07-07 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040148-005 | NORCO | 325MG;5MG | TABLET / ORAL | 2014-07-07 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040148-001 | NORCO | 325MG;10MG | TABLET / ORAL | 1997-02-14 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040148-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;10MG | TABLET / ORAL | 1997-02-14 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040148-003 | NORCO | 325MG;7.5MG | TABLET / ORAL | 2000-09-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040148-004 | NORCO | 325MG;2.5MG | TABLET / ORAL | 2014-07-07 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040148-005 | NORCO | 325MG;5MG | TABLET / ORAL | 2014-07-07 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040148-001 | NORCO | 325MG;10MG | TABLET / ORAL | 1997-02-14 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040148-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;10MG | TABLET / ORAL | 1997-02-14 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040148-003 | NORCO | 325MG;7.5MG | TABLET / ORAL | 2000-09-12 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040148-004 | NORCO | 325MG;2.5MG | TABLET / ORAL | 2014-07-07 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040148-005 | NORCO | 325MG;5MG | TABLET / ORAL | 2014-07-07 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040148-001 | NORCO | 325MG;10MG | TABLET / ORAL | 1997-02-14 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040148-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;10MG | TABLET / ORAL | 1997-02-14 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040148-003 | NORCO | 325MG;7.5MG | TABLET / ORAL | 2000-09-12 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040148-004 | NORCO | 325MG;2.5MG | TABLET / ORAL | 2014-07-07 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040148-005 | NORCO | 325MG;5MG | TABLET / ORAL | 2014-07-07 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040148-001 | NORCO | 325MG;10MG | TABLET / ORAL | 1997-02-14 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040148-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;10MG | TABLET / ORAL | 1997-02-14 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040148-003 | NORCO | 325MG;7.5MG | TABLET / ORAL | 2000-09-12 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040148-004 | NORCO | 325MG;2.5MG | TABLET / ORAL | 2014-07-07 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040148-005 | NORCO | 325MG;5MG | TABLET / ORAL | 2014-07-07 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040148-001 | NORCO | 325MG;10MG | TABLET / ORAL | 1997-02-14 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040148-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 500MG;10MG | TABLET / ORAL | 1997-02-14 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040148-003 | NORCO | 325MG;7.5MG | TABLET / ORAL | 2000-09-12 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040148-004 | NORCO | 325MG;2.5MG | TABLET / ORAL | 2014-07-07 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040148-005 | NORCO | 325MG;5MG | TABLET / ORAL | 2014-07-07 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A040148-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040148-003 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040148-004 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040148-005 | AA | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040148-001 | AA | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040148-003 | AA | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040148-004 | AA | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040148-005 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040148-001 | AA | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A040148-003 | AA | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A040148-004 | AA | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A040148-005 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040148-001 | AA | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A040148-003 | AA | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A040148-004 | AA | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A040148-005 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040148-001 | AA | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A040148-003 | AA | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A040148-004 | AA | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A040148-005 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A040148-001 | AA | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A040148-003 | AA | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A040148-004 | AA | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A040148-005 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A040148-001 | AA | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A040148-003 | AA | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A040148-004 | AA | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A040148-005 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040148-001 | AA | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A040148-003 | AA | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A040148-004 | AA | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A040148-005 | AA | 1 | ea99ee380514… |
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.
| 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 | Norco |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0023-6021 | Norco | Hydrocodone Bitartrate and Acetaminophen | Allergan, Inc. | ANDA | Current |
| 0023-6021 | Norco | Hydrocodone Bitartrate and Acetaminophen | Allergan, Inc. | ANDA | Current |
| 0023-6021 | Norco | Hydrocodone Bitartrate and Acetaminophen | Allergan, Inc. | ANDA | Current |
| 0023-6021 | Norco | Hydrocodone Bitartrate and Acetaminophen | Allergan, Inc. | ANDA | Current |
| 0023-6021 | Norco | Hydrocodone Bitartrate and Acetaminophen | Allergan, Inc. | ANDA | Current |
| 0023-6022 | Norco | Hydrocodone Bitartrate and Acetaminophen | Allergan, Inc. | ANDA | Current |
| 0023-6022 | Norco | Hydrocodone Bitartrate and Acetaminophen | Allergan, Inc. | ANDA | Current |
| 0023-6022 | Norco | Hydrocodone Bitartrate and Acetaminophen | Allergan, Inc. | ANDA | Current |
| 0023-6022 | Norco | Hydrocodone Bitartrate and Acetaminophen | Allergan, Inc. | ANDA | Current |
| 0023-6022 | Norco | Hydrocodone Bitartrate and Acetaminophen | Allergan, Inc. | ANDA | Current |
| 0591-2171 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2171 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2172 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2172 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2605 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2605 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2612 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2612 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Actavis Pharma, Inc. | ANDA | Current |
| 0904-6420 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Major Pharmaceuticals | ANDA | Current |
| 0904-6420 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Major Pharmaceuticals | ANDA | Current |
| 0904-6421 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Major Pharmaceuticals | ANDA | Current |
| 0904-6421 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Major Pharmaceuticals | ANDA | Current |
| 0904-6567 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Major Pharmaceuticals | ANDA | Current |
| 0904-6567 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Major Pharmaceuticals | ANDA | Current |
| 50436-2171 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Unit Dose Services | ANDA | Current |
| 50436-2605 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Unit Dose Services | ANDA | Current |
| 50436-2612 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Unit Dose Services | ANDA | Current |
| 52544-071 | Norco | Hydrocodone Bitatrate and Acetaminophen | Actavis Pharma, Inc. | ANDA | Current |
| 52544-161 | Norco | Hydrocodone Bitatrate and Acetaminophen | Actavis Pharma, Inc. | ANDA | Current |
| 52544-162 | Norco | Hydrocodone Bitatrate and Acetaminophen | Actavis Pharma, Inc. | ANDA | Current |
| 53217-192 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 55700-216 | Hydrocodone Bitatrate and Acetaminophen | Hydrocodone Bitatrate and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 63187-838 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 63187-838 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 65084-288 | Norco | Hydrocodone Bitatrate and Acetaminophen | Mckesson Rxpak Inc | ANDA | Current |
| 65084-453 | Hydrocodone Bitatrate and Acetaminophen | Hydrocodone Bitatrate and Acetaminophen | Mckesson Rxpak Inc | ANDA | Current |
| 68084-884 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | American Health Packaging | ANDA | Current |