Morphine Sulfate
- Product NDC
- 76329-1912
- 11-digit product format
- 763291912
- Labeler code
- 76329
- Product ID
- 76329-1912_99799101-d92b-485b-93ec-f2b5a2e5ca26
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Morphine Sulfate
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- International Medication Systems, Limited
- Application
- ANDA202861
- Marketing category
- ANDA
- Marketing start
- 2022-01-20
- Substance
- MORPHINE SULFATE
- Active strength
- 1 mg/30mL
- 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 | 1 mg/30mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X3P646A2J0 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76329-1912-0 | Morphine Sulfate | 30 mL in 1 VIAL | INJECTION | 30 | | 8 |
| 76329-1912-1 | Morphine Sulfate | 10 in 1 PACKAGE | INJECTION | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76329-1912 | MORPHINE SULFATE (MORPHINE SULFATE ) INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250112_1034467f-d436-4b87-a902-c7e8885daa8a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76329-1912-0 | 76329191200 | 30 mL in 1 VIAL | 30 ml | | | | | Historical |
| 76329-1912-1 | 76329191201 | 10 VIAL in 1 PACKAGE (76329-1912-1) / 30 mL in 1 VIAL (76329-1912-0) | 10 vial | 2022-01-20 | 0000-00-00 | No | No | Current |