Oxymorphone hydrochloride
- Product NDC
- 64896-696
- 11-digit product format
- 648960696
- Labeler code
- 64896
- Product ID
- 64896-696_4f08b804-ef2d-4c9b-8553-c2bc7fa1fd71
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxymorphone hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA079087
- Marketing category
- ANDA
- Marketing start
- 2013-01-02
- Substance
- OXYMORPHONE HYDROCHLORIDE
- Active strength
- 7.5 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oxymorphone hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OXYMORPHONE HYDROCHLORIDE | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5Y2EI94NBC |
| Rxcui | 977874, 977894, 977902, 977909, 977915, 977923, 977929 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64896-696-01 | Oxymorphone hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 15 |
| 64896-696-03 | Oxymorphone hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 1000 | | 15 |
| 64896-696-08 | Oxymorphone hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 15 |
| 64896-696-13 | Oxymorphone hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64896-696 | OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC] | 8 | Current NDC, Legacy NDC, 4 package rows | 20241025_3f4e703a-e398-42fd-8759-e398c79955f1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64896-696-01 | 64896069601 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-696-01) | 2013-01-02 | 0000-00-00 | No | No | Current |
| 64896-696-03 | 64896069603 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-696-03) | 2013-01-02 | 0000-00-00 | No | No | Current |
| 64896-696-08 | 64896069608 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-696-08) | 2013-01-02 | 0000-00-00 | No | No | Current |
| 64896-696-13 | 64896069613 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-696-13) | 2013-01-02 | 0000-00-00 | No | No | Current |