Morphine Sulfate
- Product NDC
- 0641-6191
- 11-digit product format
- 006416191
- Labeler code
- 0641
- Product ID
- 0641-6191_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
- 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
- Morphine Sulfate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MORPHINE SULFATE | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X3P646A2J0 |
| Rxcui | 998212, 998213 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0641-6191-10 | Morphine Sulfate | 1 mL in 1 SYRINGE | INJECTION | 1 | | 5 |
| 0641-6191-10 | Morphine Sulfate | 10 in 1 PACKAGE | INJECTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0641-6191 | MORPHINE SULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 5 | Current NDC, 2 package rows | 20250515_69a0d5be-3211-4b7f-962b-e9d9a507321f.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 |
|---|
| 0641-6191-10 | 00641619110 | 10 SYRINGE in 1 PACKAGE (0641-6191-10) / 1 mL in 1 SYRINGE | 10 syringe | 2025-04-18 | No | No | Current |