Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 13107-020
- 11-digit product format
- 131070020
- Labeler code
- 13107
- Product ID
- 13107-020_7f417649-a59e-4737-9535-ef865ab1f076
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurolife Pharma, LLC
- Application
- ANDA201013
- Marketing category
- ANDA
- Marketing start
- 2012-04-11
- 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
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 |
| 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 |
| 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 |
| 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 |
| 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 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydrocodone Bitartrate and Acetaminophen
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROCODONE BITARTRATE | 325 mg/1 |
| ACETAMINOPHEN | 7.5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| NO70W886KK | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 60f43308-1deb-4f05-8f17-aa49ebdcf498 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 13107-020-01 | Hydrocodone Bitartrate and Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | 19 | |
| 13107-020-05 | Hydrocodone Bitartrate and Acetaminophen | 500 in 1 BOTTLE | TABLET | 500 | 19 | |
| 13107-020-30 | Hydrocodone Bitartrate and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | 19 | |
| 13107-020-99 | Hydrocodone Bitartrate and Acetaminophen | 1000 in 1 BOTTLE | TABLET | 1000 | 19 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 13107-020-01 | EA - Each | 13107-020 | 4e036482-3169-422f-abe9-f21388701b91 | 1 | 2013-02-13 |
| 13107-020-05 | EA - Each | 13107-020 | 090cd39b-1b7f-4875-8f96-0be084ba3866 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 856999 | HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral Tablet | PSN | 60f43308-1deb-4f05-8f17-aa49ebdcf498 | 19 |
| 857002 | HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet | PSN | 60f43308-1deb-4f05-8f17-aa49ebdcf498 | 19 |
| 857005 | HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral Tablet | PSN | 60f43308-1deb-4f05-8f17-aa49ebdcf498 | 19 |
| 856999 | acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral Tablet | SCD | 60f43308-1deb-4f05-8f17-aa49ebdcf498 | 19 |
| 857002 | acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet | SCD | 60f43308-1deb-4f05-8f17-aa49ebdcf498 | 19 |
| 857005 | acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet | SCD | 60f43308-1deb-4f05-8f17-aa49ebdcf498 | 19 |
| 856999 | APAP 325 MG / hydrocodone bitartrate 10 MG Oral Tablet | SY | 60f43308-1deb-4f05-8f17-aa49ebdcf498 | 19 |
| 857002 | APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet | SY | 60f43308-1deb-4f05-8f17-aa49ebdcf498 | 19 |
| 857005 | APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet | SY | 60f43308-1deb-4f05-8f17-aa49ebdcf498 | 19 |
| 857005 | HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral Tablet | PSN | 59a92d79-5b2d-4c10-b0ac-ea766a0ff08b | 8 |
| 857005 | acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet | SCD | 59a92d79-5b2d-4c10-b0ac-ea766a0ff08b | 8 |
| 857005 | APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet | SY | 59a92d79-5b2d-4c10-b0ac-ea766a0ff08b | 8 |
| 857005 | HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral Tablet | PSN | e6711f26-a01d-43e8-882a-d58561e4b67f | 6 |
| 857005 | acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet | SCD | e6711f26-a01d-43e8-882a-d58561e4b67f | 6 |
| 857005 | APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet | SY | e6711f26-a01d-43e8-882a-d58561e4b67f | 6 |
| 856999 | HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral Tablet | PSN | d8d44758-d9a9-45dc-854d-8c30a52fa955 | 4 |
| 857002 | HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet | PSN | d8d44758-d9a9-45dc-854d-8c30a52fa955 | 4 |
| 857005 | HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral Tablet | PSN | d8d44758-d9a9-45dc-854d-8c30a52fa955 | 4 |
| 856999 | acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral Tablet | SCD | d8d44758-d9a9-45dc-854d-8c30a52fa955 | 4 |
| 857002 | acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet | SCD | d8d44758-d9a9-45dc-854d-8c30a52fa955 | 4 |
| 857005 | acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet | SCD | d8d44758-d9a9-45dc-854d-8c30a52fa955 | 4 |
| 856999 | APAP 325 MG / hydrocodone bitartrate 10 MG Oral Tablet | SY | d8d44758-d9a9-45dc-854d-8c30a52fa955 | 4 |
| 857002 | APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet | SY | d8d44758-d9a9-45dc-854d-8c30a52fa955 | 4 |
| 857005 | APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet | SY | d8d44758-d9a9-45dc-854d-8c30a52fa955 | 4 |
| 857005 | HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral Tablet | PSN | 8b269d2a-3d8e-9504-e053-2995a90a17a9 | 3 |
| 857005 | HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral Tablet | PSN | 36710b35-419c-4e64-8bd1-29b81a4c8e03 | 3 |
| 857005 | acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet | SCD | 36710b35-419c-4e64-8bd1-29b81a4c8e03 | 3 |
| 857005 | acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet | SCD | 8b269d2a-3d8e-9504-e053-2995a90a17a9 | 3 |
| 857005 | APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet | SY | 8b269d2a-3d8e-9504-e053-2995a90a17a9 | 3 |
| 857005 | APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet | SY | 36710b35-419c-4e64-8bd1-29b81a4c8e03 | 3 |
| 857005 | HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral Tablet | PSN | a62b731d-6ec2-4429-9883-b53f0e2b40a9 | 1 |
| 857005 | HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral Tablet | PSN | 8e4920b4-c7f6-4cf1-e053-2a95a90a8ea5 | 1 |
| 857005 | acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet | SCD | a62b731d-6ec2-4429-9883-b53f0e2b40a9 | 1 |
| 857005 | acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet | SCD | 8e4920b4-c7f6-4cf1-e053-2a95a90a8ea5 | 1 |
| 857005 | APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet | SY | a62b731d-6ec2-4429-9883-b53f0e2b40a9 | 1 |
| 857005 | APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet | SY | 8e4920b4-c7f6-4cf1-e053-2a95a90a8ea5 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 13107-020-01 | 13107002001 | 100 TABLET in 1 BOTTLE (13107-020-01) | 100 tablet | 2012-04-11 | 0000-00-00 | No | No | Current |
| 13107-020-05 | 13107002005 | 500 TABLET in 1 BOTTLE (13107-020-05) | 500 tablet | 2012-04-11 | 0000-00-00 | No | No | Current |
| 13107-020-30 | 13107002030 | 30 TABLET in 1 BOTTLE (13107-020-30) | 30 tablet | 2012-04-11 | 0000-00-00 | No | No | Current |
| 13107-020-99 | 13107002099 | 1000 TABLET in 1 BOTTLE (13107-020-99) | 1000 tablet | 2012-04-11 | 0000-00-00 | No | No | Current |