Oxycodone and Acetaminophen
- Product NDC
- 68308-475
- 11-digit product format
- 683080475
- Labeler code
- 68308
- Product ID
- 68308-475_151b3ec5-d0f2-446d-9db9-c9e5238fb5ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone Hydrochloride and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mayne Pharma Inc.
- Application
- ANDA090177
- Marketing category
- ANDA
- Marketing start
- 2008-12-16
- 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
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68308-475 | OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [MAYNE PHARMA INC.] | 14 | Legacy NDC | 20221223_205be197-5ad5-4849-bc78-5fda9927b531.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68308-475-47 | 68308047547 | 10 BLISTER PACK in 1 CARTON (68308-475-47) > 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2008-12-16 | 0000-00-00 | No | No | Current |