Oxymorphone Hydrochloride
- Product NDC
- 42806-330
- 11-digit product format
- 428060330
- Labeler code
- 42806
- Product ID
- 42806-330_8a01b8b5-5114-46e2-9949-1ab6beb78d81
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxymorphone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Epic Pharma, LLC
- Application
- ANDA201187
- Marketing category
- ANDA
- Marketing start
- 2019-05-15
- Substance
- OXYMORPHONE HYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oxymorphone Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OXYMORPHONE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5Y2EI94NBC |
| Rxcui | 977939, 977942 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42806-330-01 | Oxymorphone Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42806-330 | OXYMORPHONE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] | 10 | Current NDC, Legacy NDC, 1 package rows | 20241222_95804e72-232d-425d-b23d-a66f43bdf0c6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42806-330-01 | 42806033001 | 100 TABLET in 1 BOTTLE (42806-330-01) | 100 tablet | 2019-05-15 | 0000-00-00 | No | No | Current |