Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 63304-497
- 11-digit product format
- 633040497
- Labeler code
- 63304
- Product ID
- 63304-497_4f875c7a-4454-45a2-bf55-fcc2932c51db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA040826
- Marketing category
- ANDA
- Marketing start
- 2018-07-31
- 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
- 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 |
|---|
| 63304-497-01 | 63304049701 | 100 TABLET in 1 BOTTLE (63304-497-01) | 100 tablet | 2018-07-31 | No | No | Historical |
| 63304-497-03 | 63304049703 | 10 TABLET in 1 BOTTLE (63304-497-03) | 10 tablet | 2018-07-31 | No | No | Historical |
| 63304-497-05 | 63304049705 | 500 TABLET in 1 BOTTLE (63304-497-05) | 500 tablet | 2018-07-31 | No | No | Historical |
| 63304-497-10 | 63304049710 | 1000 TABLET in 1 BOTTLE (63304-497-10) | 1000 tablet | 2018-07-31 | No | No | Historical |
| 63304-497-69 | 63304049769 | 10 BLISTER PACK in 1 CARTON (63304-497-69) / 1 TABLET in 1 BLISTER PACK (63304-497-11) | 10 blister pack | 2018-07-31 | No | No | Historical |