Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 63187-658
- 11-digit product format
- 631870658
- Labeler code
- 63187
- Product ID
- 63187-658_53d10ccb-24f8-4d73-89ee-22bd08590f0a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA201013
- Marketing category
- ANDA
- Marketing start
- 2012-04-12
- 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
- 2026-12-31
- 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 |
|---|
| 63187-658-12 | 63187065812 | 12 TABLET in 1 BOTTLE (63187-658-12) | 12 tablet | 2021-03-03 | No | No | Historical |
| 63187-658-15 | 63187065815 | 15 TABLET in 1 BOTTLE (63187-658-15) | 15 tablet | 2016-03-01 | No | No | Historical |
| 63187-658-20 | 63187065820 | 20 TABLET in 1 BOTTLE (63187-658-20) | 20 tablet | 2016-03-01 | No | No | Historical |
| 63187-658-30 | 63187065830 | 30 TABLET in 1 BOTTLE (63187-658-30) | 30 tablet | 2017-05-01 | No | No | Historical |
| 63187-658-60 | 63187065860 | 60 TABLET in 1 BOTTLE (63187-658-60) | 60 tablet | 2018-01-01 | No | No | Historical |
| 63187-658-90 | 63187065890 | 90 TABLET in 1 BOTTLE (63187-658-90) | 90 tablet | 2016-03-01 | No | No | Historical |