Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 27808-116
- 11-digit product format
- 278080116
- Labeler code
- 27808
- Product ID
- 27808-116_b87bebc7-651b-4b88-8921-cfddb4265559
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cranbury Pharmaceuticals, LLC
- Application
- ANDA202214
- Marketing category
- ANDA
- Marketing start
- 2016-04-07
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 300; 10 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
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 27808-116-01 | Hydrocodone Bitartrate and Acetaminophen | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 30 | |
| 27808-116-02 | Hydrocodone Bitartrate and Acetaminophen | 500 in 1 BOTTLE | TABLET | 500 | 30 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 27808-116-01 | EA - Each | 27808-116 | 194c1cf2-cc26-488a-b6df-90fcea8f8098 | 1 | 2016-06-14 |
| 27808-116-02 | EA - Each | 27808-116 | 58a4acbf-2a2c-4c4a-9838-d647d7d99a7c | 1 | 2016-06-14 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 856980 | HYDROcodone bitartrate 10 MG / acetaminophen 300 MG Oral Tablet | PSN | 3aa038f9-f837-466f-aa3c-68a7bd0b2388 | 105 |
| 856980 | acetaminophen 300 MG / hydrocodone bitartrate 10 MG Oral Tablet | SCD | 3aa038f9-f837-466f-aa3c-68a7bd0b2388 | 105 |
| 856980 | APAP 300 MG / hydrocodone bitartrate 10 MG Oral Tablet | SY | 3aa038f9-f837-466f-aa3c-68a7bd0b2388 | 105 |
| 856980 | HYDROcodone bitartrate 10 MG / acetaminophen 300 MG Oral Tablet | PSN | e5d6de20-c195-4b97-963a-2f3832e50b49 | 103 |
| 856980 | acetaminophen 300 MG / hydrocodone bitartrate 10 MG Oral Tablet | SCD | e5d6de20-c195-4b97-963a-2f3832e50b49 | 103 |
| 856980 | APAP 300 MG / hydrocodone bitartrate 10 MG Oral Tablet | SY | e5d6de20-c195-4b97-963a-2f3832e50b49 | 103 |
| 856980 | HYDROcodone bitartrate 10 MG / acetaminophen 300 MG Oral Tablet | PSN | d8fe4ae4-bd19-42eb-b74d-f302b3f914ee | 30 |
| 856987 | HYDROcodone bitartrate 5 MG / acetaminophen 300 MG Oral Tablet | PSN | d8fe4ae4-bd19-42eb-b74d-f302b3f914ee | 30 |
| 856992 | HYDROcodone bitartrate 7.5 MG / acetaminophen 300 MG Oral Tablet | PSN | d8fe4ae4-bd19-42eb-b74d-f302b3f914ee | 30 |
| 856980 | acetaminophen 300 MG / hydrocodone bitartrate 10 MG Oral Tablet | SCD | d8fe4ae4-bd19-42eb-b74d-f302b3f914ee | 30 |
| 856987 | acetaminophen 300 MG / hydrocodone bitartrate 5 MG Oral Tablet | SCD | d8fe4ae4-bd19-42eb-b74d-f302b3f914ee | 30 |
| 856992 | acetaminophen 300 MG / hydrocodone bitartrate 7.5 MG Oral Tablet | SCD | d8fe4ae4-bd19-42eb-b74d-f302b3f914ee | 30 |
| 856980 | APAP 300 MG / hydrocodone bitartrate 10 MG Oral Tablet | SY | d8fe4ae4-bd19-42eb-b74d-f302b3f914ee | 30 |
| 856987 | APAP 300 MG / hydrocodone bitartrate 5 MG Oral Tablet | SY | d8fe4ae4-bd19-42eb-b74d-f302b3f914ee | 30 |
| 856992 | APAP 300 MG / Hydrocodone Bitartrate 7.5 MG Oral Tablet | SY | d8fe4ae4-bd19-42eb-b74d-f302b3f914ee | 30 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 27808-116-01 | 27808011601 | 100 TABLET in 1 BOTTLE, PLASTIC (27808-116-01) | 100 tablet | 2016-04-07 | 0000-00-00 | No | No | Current |
| 27808-116-02 | 27808011602 | 500 TABLET in 1 BOTTLE (27808-116-02) | 500 tablet | 2016-04-07 | 0000-00-00 | No | No | Current |