Oxymorphone Hydrochloride
- Product NDC
- 0406-8095
- 11-digit product format
- 004068095
- Labeler code
- 0406
- Product ID
- 0406-8095_52decd34-d8ac-407b-8c21-dd6d21b44be3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxymorphone Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- SpecGx LLC
- Application
- ANDA202946
- Marketing category
- ANDA
- Marketing start
- 2014-06-27
- Marketing end
- 0000-00-00
- Substance
- OXYMORPHONE HYDROCHLORIDE
- Active strength
- 8 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record