Morphine Sulfate
- Product NDC
- 0406-5119
- 11-digit product format
- 004065119
- Labeler code
- 0406
- Product ID
- 0406-5119_675ff1e4-12b4-4141-8811-ef442950ea23
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Morphine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- SpecGx LLC
- Application
- ANDA215194
- Marketing category
- ANDA
- Marketing start
- 2023-09-01
- Substance
- MORPHINE SULFATE
- Active strength
- 30 mg/1
- 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 | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X3P646A2J0 |
| Rxcui | 892582, 892672 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0406-5119-01 | Morphine Sulfate | 100 in 1 BOTTLE | TABLET | 100 | | 9 |
| 0406-5119-62 | Morphine Sulfate | 10 in 1 CARTON | TABLET | 10 | | 9 |
| 0406-5119-62 | Morphine Sulfate | 10 in 1 BLISTER PACK | TABLET | 10 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0406-5119 | MORPHINE SULFATE TABLET [SPECGX LLC] | 8 | Current NDC, 3 package rows | 20240503_8b69f67f-30b3-4982-953e-5a4b87ec6ac6.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 |
|---|
| 0406-5119-01 | 00406511901 | 100 TABLET in 1 BOTTLE (0406-5119-01) | 100 tablet | 2023-09-01 | No | No | Historical |
| 0406-5119-62 | 00406511962 | 10 BLISTER PACK in 1 CARTON (0406-5119-62) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2023-09-01 | No | No | Historical |