Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 63187-112
- 11-digit product format
- 631870112
- Labeler code
- 63187
- Product ID
- 63187-112_160e7aae-4a67-4845-9fa1-9d13afb5285d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA040736
- Marketing category
- ANDA
- Marketing start
- 2010-01-18
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325; 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 |
|---|
| 63187-112-15 | 63187011215 | 15 TABLET in 1 BOTTLE (63187-112-15) | 15 tablet | 2014-06-02 | No | No | Historical |
| 63187-112-20 | 63187011220 | 20 TABLET in 1 BOTTLE (63187-112-20) | 20 tablet | 2014-06-02 | No | No | Historical |
| 63187-112-30 | 63187011230 | 30 TABLET in 1 BOTTLE (63187-112-30) | 30 tablet | 2014-06-02 | No | No | Historical |
| 63187-112-60 | 63187011260 | 60 TABLET in 1 BOTTLE (63187-112-60) | 60 tablet | 2014-06-02 | No | No | Historical |