Morphine Sulfate
- Product NDC
- 0641-6192
- 11-digit product format
- 006416192
- Labeler code
- 0641
- Product ID
- 0641-6192_cbc693d6-fa17-4710-b91f-22c4f5d74793
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Morphine Sulfate
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA211452
- Marketing category
- ANDA
- Marketing start
- 2025-04-18
- Substance
- MORPHINE SULFATE
- Active strength
- 4 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 |
|---|
| X3P646A2J0 | MORPHINE SULFATE | 6211-15-0 | MORPHINE SULFATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0641-6192-10 | 00641619210 | 10 SYRINGE in 1 PACKAGE (0641-6192-10) / 1 mL in 1 SYRINGE | 10 syringe | 2025-04-18 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Morphine Sulfate | Hikma Pharmaceuticals USA Inc. | 2025-05-13 | HUMAN PRESCRIPTION DRUG LABEL | 5 |