HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Product NDC
- 55700-991
- 11-digit product format
- 557000991
- Labeler code
- 55700
- Product ID
- 55700-991_d63ec86d-5a5f-44ab-b335-040f0093cb64
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA040400
- Marketing category
- ANDA
- Marketing start
- 2022-12-27
- Marketing end
- 2027-05-31
- 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
- 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 |
|---|
| 55700-991-30 | 55700099130 | 30 TABLET in 1 BOTTLE (55700-991-30) | 30 tablet | 2022-12-27 | 2027-05-31 | No | No | Historical |
| 55700-991-60 | 55700099160 | 60 TABLET in 1 BOTTLE (55700-991-60) | 60 tablet | 2022-12-27 | 2027-05-31 | No | No | Historical |
| 55700-991-90 | 55700099190 | 90 TABLET in 1 BOTTLE (55700-991-90) | 90 tablet | 2022-12-27 | 2027-05-31 | No | No | Historical |