Oxymorphone Hydrochloride
- Product NDC
- 0054-0283
- 11-digit product format
- 000540283
- Labeler code
- 0054
- Product ID
- 0054-0283_74519e3e-078f-42ea-882e-1df0eb0eaaee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxymorphone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA090964
- Marketing category
- ANDA
- Marketing start
- 2010-09-27
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0283-25 | Oxymorphone Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 18 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0283 | OXYMORPHONE HYDROCHLORIDE TABLET [HIKMA PHARMACEUTICALS USA INC.] | 15 | Current NDC, Legacy NDC, 1 package rows | 20240203_3eb971cf-ab82-49f3-a46c-4d76a8ce599e.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 |
|---|
| 0054-0283-25 | 00054028325 | 100 TABLET in 1 BOTTLE (0054-0283-25) | 100 tablet | 2010-09-27 | 0000-00-00 | No | No | Current |