Oxycodone and Acetaminophen
- Product NDC
- 0603-4982
- 11-digit product format
- 006034982
- Labeler code
- 0603
- Product ID
- 0603-4982_18d75374-066d-4bc1-8ab6-be4312a65b2c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone hydrochloride and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Par Pharmaceutical, Inc.
- Application
- ANDA090734
- Marketing category
- ANDA
- Marketing start
- 2013-07-11
- Marketing end
- 2021-10-31
- Substance
- OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
- Active strength
- 10 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 |
|---|
| 0603-4982-21 | 00603498221 | 100 TABLET in 1 BOTTLE, PLASTIC (0603-4982-21) | 100 tablet | 2013-07-11 | 2021-10-31 | No | No | Current |
| 0603-4982-28 | 00603498228 | 500 TABLET in 1 BOTTLE, PLASTIC (0603-4982-28) | 500 tablet | 2013-07-11 | 2021-10-31 | No | No | Current |