Morphine Sulfate
- Product NDC
- 0121-4955
- 11-digit product format
- 001214955
- Labeler code
- 0121
- Product ID
- 0121-4955_8a1bb0fe-ab24-4c30-b843-d06c61fcf0cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MORPHINE SULFATE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA206573
- Marketing category
- ANDA
- Marketing start
- 2025-09-15
- Substance
- MORPHINE SULFATE
- Active strength
- 10 mg/5mL
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Morphine Sulfate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MORPHINE SULFATE | 10 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X3P646A2J0 |
| Rxcui | 892589 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0121-4955-05 | Morphine Sulfate | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | | 21 |
| 0121-4955-94 | Morphine Sulfate | 10 in 1 TRAY | SOLUTION | 10 | | 21 |
| 0121-4955-94 | Morphine Sulfate | 3 in 1 CASE | SOLUTION | 3 | | 21 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0121-4955-05 | 00121495505 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | Historical |
| 0121-4955-94 | 00121495594 | 3 TRAY in 1 CASE (0121-4955-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4955-05) | 3 tray | 2025-09-15 | No | No | Current |