Oxymorphone Hydrochloride
- Product NDC
- 13107-103
- 11-digit product format
- 131070103
- Labeler code
- 13107
- Product ID
- 13107-103_6c5c7596-0b2c-435f-a619-706b4424370d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxymorphone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurolife Pharma, LLC
- Application
- ANDA204459
- Marketing category
- ANDA
- Marketing start
- 2016-04-26
- 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 |
|---|
| 13107-103-01 | Oxymorphone Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 15 |
| 13107-103-30 | Oxymorphone Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 15 |
| 13107-103-99 | Oxymorphone Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13107-103 | OXYMORPHONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC] | 14 | Current NDC, Legacy NDC, 3 package rows | 20240711_22c7652a-aa16-4fa8-89d9-517e69059068.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 |
|---|
| 13107-103-01 | 13107010301 | 100 TABLET in 1 BOTTLE (13107-103-01) | 100 tablet | 2016-04-26 | 0000-00-00 | No | No | Current |
| 13107-103-30 | 13107010330 | 30 TABLET in 1 BOTTLE (13107-103-30) | 30 tablet | 2016-04-26 | 0000-00-00 | No | No | Current |
| 13107-103-99 | 13107010399 | 1000 TABLET in 1 BOTTLE (13107-103-99) | 1000 tablet | 2016-04-26 | 0000-00-00 | No | No | Current |