Morphine Sulfate
- Product NDC
- 0406-8003
- 11-digit product format
- 004068003
- Labeler code
- 0406
- Product ID
- 0406-8003_852596c9-601f-477c-9966-580f728d9e54
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- morphine sulfate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- SpecGx LLC
- Application
- ANDA202348
- Marketing category
- ANDA
- Marketing start
- 2011-07-15
- Substance
- MORPHINE SULFATE
- Active strength
- 20 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 | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X3P646A2J0 |
| Rxcui | 892625 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MORPHINE SULFATE | ACTIVE INGREDIENT | X3P646A2J0 | MORPHINE SULFATE SOLUTION [MALLINCKRODT, INC.] | 10 | |
| MORPHINE | ACTIVE MOIETY | 76I7G6D29C | MORPHINE SULFATE SOLUTION [MALLINCKRODT, INC.] | 10 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | MORPHINE SULFATE SOLUTION [MALLINCKRODT, INC.] | 10 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | MORPHINE SULFATE SOLUTION [MALLINCKRODT, INC.] | 10 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | MORPHINE SULFATE SOLUTION [MALLINCKRODT, INC.] | 10 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | MORPHINE SULFATE SOLUTION [MALLINCKRODT, INC.] | 10 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | MORPHINE SULFATE SOLUTION [MALLINCKRODT, INC.] | 10 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | MORPHINE SULFATE SOLUTION [MALLINCKRODT, INC.] | 10 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | MORPHINE SULFATE SOLUTION [MALLINCKRODT, INC.] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0406-8003 | MORPHINE SULFATE SOLUTION [SPECGX LLC] | 26 | Current NDC, Legacy NDC, 8 package rows | 20240724_242c2512-1d49-486b-a9c3-6905f667799e.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 |
|---|
| 0406-8003-12 | 00406800312 | 6 CARTON in 1 CASE (0406-8003-12) / 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC | 6 carton | 2011-07-15 | 0000-00-00 | No | No | Current |
| 0406-8003-15 | 00406800315 | 6 CARTON in 1 CASE (0406-8003-15) / 1 BOTTLE, PLASTIC in 1 CARTON / 15 mL in 1 BOTTLE, PLASTIC | 6 carton | 2011-07-15 | 0000-00-00 | No | No | Current |
| 0406-8003-24 | 00406800324 | 6 CARTON in 1 CASE (0406-8003-24) / 1 BOTTLE, PLASTIC in 1 CARTON / 240 mL in 1 BOTTLE, PLASTIC | 6 carton | 2011-07-15 | 0000-00-00 | No | No | Current |
| 0406-8003-30 | 00406800330 | 6 CARTON in 1 CASE (0406-8003-30) / 1 BOTTLE, PLASTIC in 1 CARTON / 30 mL in 1 BOTTLE, PLASTIC | 6 carton | 2011-07-15 | 0000-00-00 | No | No | Current |