Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 71335-1557
- 11-digit product format
- 713351557
- Labeler code
- 71335
- Product ID
- 71335-1557_1c2f7b86-fbb6-4c74-9a7b-17a016955aaf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202991
- Marketing category
- ANDA
- Marketing start
- 2016-04-12
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Hydrocodone Bitartrate and Acetaminophen
- Listing expiration
- 2027-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| HYDROCODONE BITARTRATE | 7.5 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 362O9ITL9D, NO70W886KK |
| Rxcui | 857005 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 362O9ITL9D | ACETAMINOPHEN | 103-90-2 | ACETAMINOPHEN |
| NO70W886KK | HYDROCODONE BITARTRATE | 34195-34-1 | HYDROCODONE BITARTRATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1557-1 | 71335155701 | 21 TABLET in 1 BOTTLE (71335-1557-1) | 21 tablet | 2021-06-07 | 0000-00-00 | No | No | Current |
| 71335-1557-2 | 71335155702 | 36 TABLET in 1 BOTTLE (71335-1557-2) | 36 tablet | 2020-04-02 | 0000-00-00 | No | No | Current |
| 71335-1557-3 | 71335155703 | 10 TABLET in 1 BOTTLE (71335-1557-3) | 10 tablet | 2026-05-13 | | No | No | Historical |