hydrocodone bitartrate and acetaminophen
- Product NDC
- 63629-1184
- 11-digit product format
- 636291184
- Labeler code
- 63629
- Product ID
- 63629-1184_9df309b1-d246-4eb4-b91b-e326c86c1751
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocodone bitartrate and acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA207509
- Marketing category
- ANDA
- Marketing start
- 2020-09-01
- 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
- 2027-12-31
- Current FDA listing
- Yes
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 | Sample | Exclude flag | Status |
|---|
| 63629-1184-1 | 63629118401 | 500 TABLET in 1 BOTTLE (63629-1184-1) | 500 tablet | 2020-09-01 | No | No | Historical |