Oxycodone and Acetaminophen
- Product NDC
- 0904-6438
- 11-digit product format
- 009046438
- Labeler code
- 0904
- Product ID
- 0904-6438_1e3e98ed-ef89-4d6d-b404-6714fdfd8881
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone hydrochloride and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA090734
- Marketing category
- ANDA
- Marketing start
- 2015-03-25
- 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
- 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 |
|---|
| 0904-6438-61 | 00904643861 | 100 BLISTER PACK in 1 CARTON (0904-6438-61) > 1 TABLET in 1 BLISTER PACK | 100 blister pack | 2015-03-25 | 0000-00-00 | No | No | Current |