Application 201013
- Type
- ANDA
- Sponsor
- AUROLIFE PHARMA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;5MG | No | No |
| 002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;7.5MG | No | No |
| 003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A201013-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;5MG | TABLET / ORAL | AA | 2012-04-11 | |
| A201013-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET / ORAL | AA | 2012-04-11 | |
| A201013-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET / ORAL | AA | 2012-04-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A201013-001 | AA |
| A201013-002 | AA |
| A201013-003 | 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A201013-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2012-04-11 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A201013-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2012-04-11 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A201013-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2012-04-11 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A201013-001 | AA | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A201013-002 | AA | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A201013-003 | AA | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | ddfe71cc-27bf-4807-b62f-e6cf982e2dfd | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | 201013 ANDA201013 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 88c031ee-3d3d-4e8a-b69b-d18db612a9f3 | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | 201013 ANDA201013 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Aurolife Pharma, LLC | 60f43308-1deb-4f05-8f17-aa49ebdcf498 | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | 201013 ANDA201013 13107-020 13107-021 13107-019 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 59a92d79-5b2d-4c10-b0ac-ea766a0ff08b | 2024-10-08 | Boxed warning, Warnings, Adverse reactions | 201013 ANDA201013 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 8b132cf3-c138-59ae-e053-2995a90a98a2 | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | 201013 ANDA201013 66267-319 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 8c2a7a68-5a84-c909-e053-2995a90ad5b6 | 2024-06-18 | Boxed warning, Warnings, Adverse reactions | 201013 ANDA201013 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 8592e901-9353-6fb6-e053-2a91aa0ad33b | 2024-06-14 | Boxed warning, Warnings, Adverse reactions | 201013 ANDA201013 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 86be8920-2f35-fbc3-e053-2991aa0a0015 | 2024-06-14 | Boxed warning, Warnings, Adverse reactions | 201013 ANDA201013 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Proficient Rx LP | 82b24978-8b15-43a9-b5b0-3313ed2a73c2 | 2023-04-01 | Boxed warning, Warnings, Adverse reactions | 201013 ANDA201013 63187-375 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Proficient Rx LP | e6711f26-a01d-43e8-882a-d58561e4b67f | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | 201013 ANDA201013 63187-658 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Proficient Rx LP | 199d4915-cb3b-48f3-835d-a45d04a5c940 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 201013 ANDA201013 63187-778 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 13107-019 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-019 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma LLC | ANDA | Current |
| 13107-019 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma LLC | ANDA | Current |
| 13107-020 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-020 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma LLC | ANDA | Current |
| 13107-020 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma LLC | ANDA | Current |
| 13107-021 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-021 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma LLC | ANDA | Current |
| 13107-021 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma LLC | ANDA | Current |
| 35356-795 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-796 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-796 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-797 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-797 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 50090-1084 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | A-S Medication Solutions | ANDA | Current |
| 50090-2120 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | A-S Medication Solutions | ANDA | Current |
| 50090-2120 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | A-S Medication Solutions | ANDA | Current |
| 50090-2120 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | A-S Medication Solutions | ANDA | Current |
| 50090-2120 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | A-S Medication Solutions | ANDA | Current |
| 50090-2121 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | A-S Medication Solutions | ANDA | Current |
| 50090-2121 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | A-S Medication Solutions | ANDA | Current |
| 50090-2121 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | A-S Medication Solutions | ANDA | Current |
| 50090-2229 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | A-S Medication Solutions | ANDA | Current |
| 50090-2229 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | A-S Medication Solutions | ANDA | Current |
| 50090-2229 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | A-S Medication Solutions | ANDA | Current |
| 50090-3688 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | A-S Medication Solutions | ANDA | Current |
| 50090-3689 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | A-S Medication Solutions | ANDA | Current |
| 50090-4064 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | A-S Medication Solutions | ANDA | Current |
| 51655-804 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Northwind Pharmaceuticals | ANDA | Current |
| 51655-898 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Northwind Pharmaceuticals | ANDA | Current |
| 52959-324 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | H.J. Harkins Company, Inc. | ANDA | Current |
| 52959-735 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | H.J. Harkins Company, Inc. | ANDA | Current |
| 53217-265 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 53217-266 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 53217-267 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 60760-218 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-218 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-219 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-220 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-208 | HYRDROCODONE APAP | HYRDROCODONE APAP | Direct Rx | ANDA | Current |
| 61919-208 | HYRDROCODONE APAP | HYRDROCODONE APAP | Direct_Rx | ANDA | Current |
| 61919-208 | HYRDROCODONE APAP | HYRDROCODONE APAP | Direct_Rx | ANDA | Current |
| 61919-208 | HYRDROCODONE APAP | HYRDROCODONE APAP | Direct_Rx | ANDA | Current |
| 61919-208 | HYRDROCODONE APAP | HYRDROCODONE APAP | Direct_Rx | ANDA | Current |
| 61919-208 | HYRDROCODONE APAP | HYRDROCODONE APAP | Direct_Rx | ANDA | Current |
| 61919-618 | HYDROCODONE /APAP | HYDROCODONE /APAP | DIRECTRX | ANDA | Current |
| 61919-618 | HYDROCODONE /APAP | HYDROCODONE /APAP | Direct_Rx | ANDA | Current |
| 61919-618 | HYDROCODONE /APAP | HYDROCODONE /APAP | Direct_Rx | ANDA | Current |
| 61919-618 | HYDROCODONE /APAP | HYDROCODONE /APAP | Direct_Rx | ANDA | Current |
| 61919-618 | HYDROCODONE /APAP | HYDROCODONE /APAP | Direct_Rx | ANDA | Current |
| 61919-618 | HYDROCODONE /APAP | HYDROCODONE /APAP | Direct_Rx | ANDA | Current |
| 61919-618 | HYDROCODONE /APAP | HYDROCODONE /APAP | Direct_Rx | ANDA | Current |
| 61919-618 | HYDROCODONE /APAP | HYDROCODONE /APAP | Direct_Rx | ANDA | Current |
| 61919-618 | HYDROCODONE /APAP | HYDROCODONE /APAP | Direct_Rx | ANDA | Current |
| 61919-618 | HYDROCODONE /APAP | HYDROCODONE /APAP | Direct_Rx | ANDA | Current |
| 61919-618 | HYDROCODONE /APAP | HYDROCODONE /APAP | Direct_Rx | ANDA | Current |
| 61919-618 | HYDROCODONE /APAP | HYDROCODONE /APAP | Direct_Rx | ANDA | Current |
| 61919-828 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Direct_Rx | ANDA | Current |
| 61919-828 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Direct_Rx | ANDA | Current |
| 61919-828 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Direct_Rx | ANDA | Current |
| 61919-828 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Direct_Rx | ANDA | Current |
| 63187-375 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 63187-375 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 63187-375 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 63187-375 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 63187-658 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 63187-658 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 63187-658 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 63187-658 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 63187-778 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 63187-778 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 63187-778 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 63187-778 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 63629-7822 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 63629-7822 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 66267-319 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 66267-319 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 67296-1791 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1791 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1791 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | RedPharm Drug, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76323 | ORIG | 2023-11-03 |