HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Product NDC
- 55700-992
- 11-digit product format
- 557000992
- Labeler code
- 55700
- Product ID
- 55700-992_519df147-49f9-4a5a-a2ae-c92f094456be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA040409
- Marketing category
- ANDA
- Marketing start
- 2023-04-06
- Marketing end
- 2027-04-30
- 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
- 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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 55700-992-30 | 55700099230 | 30 TABLET in 1 BOTTLE (55700-992-30) | 30 tablet | 2023-04-06 | 2027-04-30 | No | No | Historical |
| 55700-992-60 | 55700099260 | 60 TABLET in 1 BOTTLE (55700-992-60) | 60 tablet | 2023-04-06 | 2027-04-30 | No | No | Historical |