Hydromorphone Hydrochloride
- Product NDC
- 0641-6254
- 11-digit product format
- 006416254
- Labeler code
- 0641
- Product ID
- 0641-6254_ba25ec4f-3b81-4960-bf74-6a1e4c6be45c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydromorphone Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA217812
- Marketing category
- NDA
- Marketing start
- 2025-05-13
- Substance
- HYDROMORPHONE HYDROCHLORIDE
- Active strength
- 2 mg/mL
- 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 | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L960UP2KRW |
| Rxcui | 897745 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0641-6254-01 | Hydromorphone Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 1 |
| 0641-6254-01 | Hydromorphone Hydrochloride | 20 mL in 1 VIAL | INJECTION, SOLUTION | 20 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0641-6254 | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 1 | Current NDC, 2 package rows | 20250519_c729424e-e483-4bf8-b86c-ce56636dcffa.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 |
|---|
| 0641-6254-01 | 00641625401 | 1 VIAL in 1 CARTON (0641-6254-01) / 20 mL in 1 VIAL | 1 vial | 2025-05-13 | No | No | Current |