Morphine Sulfate
- Product NDC
- 0121-0904
- 11-digit product format
- 001210904
- Labeler code
- 0121
- Product ID
- 0121-0904_3652d47b-cb6f-455b-9ed3-1726b44cd105
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Morphine Sulfate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- NDA022195
- Marketing category
- NDA
- Marketing start
- 2017-03-17
- 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
- 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 | 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 |
|---|
| 0121-0904-05 | Morphine Sulfate | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | | 10 |
| 0121-0904-94 | Morphine Sulfate | 10 in 1 TRAY | SOLUTION | 10 | | 10 |
| 0121-0904-94 | Morphine Sulfate | 3 in 1 CASE | SOLUTION | 3 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-0904 | MORPHINE SULFATE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 10 | Current NDC, Legacy NDC, 3 package rows | 20241121_6e32b869-31c7-48c1-98ae-b21bd28151d7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0121-0904-05 | 00121090405 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | | Historical |
| 0121-0904-94 | 00121090494 | 3 TRAY in 1 CASE (0121-0904-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0904-05) | 3 tray | 2020-10-09 | 0000-00-00 | No | No | Current |