Hydromorphone Hydrochloride
- Product NDC
- 43602-001
- 11-digit product format
- 436020001
- Labeler code
- 43602
- Product ID
- 43602-001_c5abd799-51be-4368-b788-b6b6c30b90af
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydromorphone Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Ascent Pharmaceuticals Inc
- Application
- ANDA210176
- Marketing category
- ANDA
- Marketing start
- 2019-05-04
- Substance
- HYDROMORPHONE HYDROCHLORIDE
- Active strength
- 5 mg/5mL
- 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
- Hydromorphone Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROMORPHONE HYDROCHLORIDE | 5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L960UP2KRW |
| Rxcui | 897657 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43602-001-47 | Hydromorphone Hydrochloride | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43602-001 | HYDROMORPHONE HYDROCHLORIDE SOLUTION [ASCENT PHARMACEUTICALS INC] | 1 | Current NDC, 1 package rows | 20240830_e8fd7b0e-22b9-4f8a-8eb2-41d5031779af.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 |
|---|
| 43602-001-47 | 43602000147 | 473 mL in 1 BOTTLE (43602-001-47) | 473 ml | 2019-05-04 | No | No | Historical |