Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 71335-2112
- 11-digit product format
- 713352112
- Labeler code
- 71335
- Product ID
- 71335-2112_c1879bd1-230a-4017-a114-4caaaea0058a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA211487
- Marketing category
- ANDA
- Marketing start
- 2018-11-08
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydrocodone Bitartrate and Acetaminophen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| HYDROCODONE BITARTRATE | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, NO70W886KK |
| Rxcui | 857005 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-2112-1 | 71335211201 | 21 TABLET in 1 BOTTLE (71335-2112-1) | 21 tablet | 2022-06-20 | 0000-00-00 | No | No | Current |
| 71335-2112-2 | 71335211202 | 36 TABLET in 1 BOTTLE (71335-2112-2) | 36 tablet | 2022-06-20 | 0000-00-00 | No | No | Current |
| 71335-2112-3 | 71335211203 | 10 TABLET in 1 BOTTLE (71335-2112-3) | 10 tablet | 2022-06-20 | | No | No | Historical |