Oxycodone and Acetaminophen
- Product NDC
- 0054-0551
- 11-digit product format
- 000540551
- Labeler code
- 0054
- Product ID
- 0054-0551_13210bf5-efba-438d-a241-858cb83fa120
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- West-Ward Pharmaceuticals Corp.
- Application
- ANDA087003
- Marketing category
- ANDA
- Marketing start
- 1991-02-01
- Marketing end
- 2021-02-28
- 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
- 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 |
|---|
| 0054-0551-24 | 00054055124 | 4 BLISTER PACK in 1 BOX (0054-0551-24) > 25 TABLET in 1 BLISTER PACK | 4 blister pack | 1991-02-01 | 2021-02-28 | No | No | Current |
| 0054-0551-25 | 00054055125 | 100 TABLET in 1 BOTTLE, PLASTIC (0054-0551-25) | 100 tablet | 1991-02-01 | 2021-02-28 | No | No | Current |
| 0054-0551-29 | 00054055129 | 500 TABLET in 1 BOTTLE, PLASTIC (0054-0551-29) | 500 tablet | 1991-02-01 | 2021-02-28 | No | No | Current |