HYDROMORPHONE HYDROCHLORIDE
- Product NDC
- 43602-004
- 11-digit product format
- 436020004
- Labeler code
- 43602
- Product ID
- 43602-004_b492adee-8ae4-476e-8047-c13fb2136b58
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydromorphone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ascent Pharmaceuticals Inc
- Application
- ANDA210506
- Marketing category
- ANDA
- Marketing start
- 2018-01-24
- Substance
- HYDROMORPHONE 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HYDROMORPHONE HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROMORPHONE HYDROCHLORIDE | 8 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L960UP2KRW |
| Rxcui | 897696, 897702, 897710 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43602-004-05 | HYDROMORPHONE HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET | 500 | | 1 |
| 43602-004-30 | HYDROMORPHONE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43602-004 | HYDROMORPHONE HYDROCHLORIDE TABLET [ASCENT PHARMACEUTICALS INC] | 1 | Current NDC, 2 package rows | 20240906_4de15afe-d676-4faa-a34d-9b9cb20dbf54.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 43602-004-05 | 43602000405 | 500 TABLET in 1 BOTTLE (43602-004-05) | 500 tablet | 2018-01-24 | No | No | Historical |
| 43602-004-30 | 43602000430 | 30 TABLET in 1 BOTTLE (43602-004-30) | 30 tablet | 2018-01-24 | No | No | Historical |