Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 63629-1941
- 11-digit product format
- 636291941
- Labeler code
- 63629
- Product ID
- 63629-1941_72330deb-c943-46a1-aca0-c73d12096ce2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA211023
- Marketing category
- ANDA
- Marketing start
- 2019-04-08
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325 mg/15mL; mg/15mL
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-1941-1 | 63629194101 | 473 mL in 1 BOTTLE (63629-1941-1) | 473 ml | 2021-12-21 | 0000-00-00 | No | No | Current |