OXYCODONE AND ACETAMINOPHEN
- Product NDC
- 63629-1943
- 11-digit product format
- 636291943
- Labeler code
- 63629
- Product ID
- 63629-1943_1c70dbce-c925-4d28-9bc9-291df101742f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxycodone and acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA207510
- Marketing category
- ANDA
- Marketing start
- 2019-06-01
- 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 |
|---|
| 63629-1943-1 | 63629194301 | 500 TABLET in 1 BOTTLE (63629-1943-1) | 500 tablet | 2021-02-10 | 0000-00-00 | No | No | Current |