Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 70518-3491
- 11-digit product format
- 705183491
- Labeler code
- 70518
- Product ID
- 70518-3491_e6d9e611-ee73-f2be-e053-2a95a90aba43
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA209036
- Marketing category
- ANDA
- Marketing start
- 2022-08-22
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 300 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3491-0 | 70518349100 | 100 POUCH in 1 BOX (70518-3491-0) > 1 TABLET in 1 POUCH (70518-3491-1) | 100 pouch | 2022-08-22 | 0000-00-00 | No | No | Current |