Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 63187-778
- 11-digit product format
- 631870778
- Labeler code
- 63187
- Product ID
- 63187-778_156868e3-86ea-4689-90b4-734d29634b29
- 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; 10 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 |
|---|
| 63187-778-12 | 63187077812 | 12 TABLET in 1 BOTTLE (63187-778-12) | 12 tablet | 2016-11-01 | No | No | Historical |
| 63187-778-15 | 63187077815 | 15 TABLET in 1 BOTTLE (63187-778-15) | 15 tablet | 2017-02-01 | No | No | Historical |
| 63187-778-20 | 63187077820 | 20 TABLET in 1 BOTTLE (63187-778-20) | 20 tablet | 2016-11-01 | No | No | Historical |
| 63187-778-30 | 63187077830 | 30 TABLET in 1 BOTTLE (63187-778-30) | 30 tablet | 2016-11-01 | No | No | Historical |
| 63187-778-60 | 63187077860 | 60 TABLET in 1 BOTTLE (63187-778-60) | 60 tablet | 2016-11-01 | No | No | Historical |
| 63187-778-90 | 63187077890 | 90 TABLET in 1 BOTTLE (63187-778-90) | 90 tablet | 2017-02-01 | No | No | Historical |