OXYCODONE/APAP
- Product NDC
- 61919-524
- 11-digit product format
- 619190524
- Labeler code
- 61919
- Product ID
- 61919-524_86e366de-fa6b-89ae-e053-2a91aa0a2fed
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OXYCODONE/APAP
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- DirectRX
- Application
- ANDA201972
- Marketing category
- ANDA
- Marketing start
- 2019-04-19
- Marketing end
- 0000-00-00
- Substance
- OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 |
|---|
| 61919-524-90 | 61919052490 | 90 TABLET in 1 BOTTLE (61919-524-90) | 90 tablet | 2019-04-19 | 0000-00-00 | No | No | Current |