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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| L960UP2KRW | HYDROMORPHONE HYDROCHLORIDE | 71-68-1 | HYDROMORPHONE HYDROCHLORIDE |
Packages
| 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 | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Hydromorphone Hydrochloride | Hikma Pharmaceuticals USA Inc. | 2023-12-15 | HUMAN PRESCRIPTION DRUG LABEL | 1 |