OXYCODONE AND ACETAMINOPHEN
- Product NDC
- 70518-3492
- 11-digit product format
- 705183492
- Labeler code
- 70518
- Product ID
- 70518-3492_e6d9606c-ac11-b89c-e053-2995a90ac780
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxycodone hydrochloride and acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA040545
- Marketing category
- ANDA
- Marketing start
- 2022-08-22
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
- Active strength
- 325 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- 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 |
|---|
| 70518-3492-0 | 70518349200 | 100 POUCH in 1 BOX (70518-3492-0) > 1 TABLET in 1 POUCH (70518-3492-1) | 100 pouch | 2022-08-22 | 0000-00-00 | No | No | Current |