OXYCODONE APAP
- Product NDC
- 61919-412
- 11-digit product format
- 619190412
- Labeler code
- 61919
- Product ID
- 61919-412_9cab4be0-985c-c53d-e053-2a95a90a6b29
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OXYCODONE APAP
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA201972
- Marketing category
- ANDA
- Marketing start
- 2018-03-14
- Marketing end
- 0000-00-00
- Substance
- OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
- Active strength
- 8 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|
| 61919-412-30 | 61919041230 | 30 TABLET in 1 BOTTLE (61919-412-30) | 30 tablet | 2018-03-14 | 0000-00-00 | No | No | Current |