Morphine Sulfate
- Product NDC
- 0054-0235
- 11-digit product format
- 000540235
- Labeler code
- 0054
- Product ID
- 0054-0235_c89c4f71-eab3-4b74-b098-fcd31d5aa0dd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Morphine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA022207
- Marketing category
- NDA
- Marketing start
- 2008-03-17
- Substance
- MORPHINE SULFATE
- Active strength
- 15 mg/1
- 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 | 15 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 |
|---|
| 0054-0235-24 | Morphine Sulfate | 1 in 1 BLISTER PACK | TABLET | 1 | | 13 |
| 0054-0235-24 | Morphine Sulfate | 100 in 1 CARTON | TABLET | 100 | | 13 |
| 0054-0235-25 | Morphine Sulfate | 100 in 1 BOTTLE | TABLET | 100 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MORPHINE SULFATE | ACTIVE INGREDIENT | X3P646A2J0 | MORPHINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.] | 7 | |
| MORPHINE | ACTIVE MOIETY | 76I7G6D29C | MORPHINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MORPHINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.] | 7 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MORPHINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.] | 7 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MORPHINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.] | 7 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | MORPHINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.] | 7 | |
| MORPHINE SULFATE | ACTIVE INGREDIENT | X3P646A2J0 | MORPHINE SULFATE TABLET [ROXANE LABORATORIES, INC] | 4 | |
| MORPHINE | ACTIVE MOIETY | 76I7G6D29C | MORPHINE SULFATE TABLET [ROXANE LABORATORIES, INC] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MORPHINE SULFATE TABLET [ROXANE LABORATORIES, INC] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MORPHINE SULFATE TABLET [ROXANE LABORATORIES, INC] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MORPHINE SULFATE TABLET [ROXANE LABORATORIES, INC] | 4 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | MORPHINE SULFATE TABLET [ROXANE LABORATORIES, INC] | 4 | |
| MORPHINE SULFATE | ACTIVE INGREDIENT | X3P646A2J0 | MORPHINE SULFATE TABLET [STAT RX USA LLC] | 2 | |
| MORPHINE SULFATE | ACTIVE INGREDIENT | X3P646A2J0 | MORPHINE SULFATE TABLET [H.J. HARKINS COMPANY, INC.] | 2 | |
| MORPHINE | ACTIVE MOIETY | 76I7G6D29C | MORPHINE SULFATE TABLET [STAT RX USA LLC] | 2 | |
| MORPHINE | ACTIVE MOIETY | 76I7G6D29C | MORPHINE SULFATE TABLET [H.J. HARKINS COMPANY, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MORPHINE SULFATE TABLET [STAT RX USA LLC] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MORPHINE SULFATE TABLET [STAT RX USA LLC] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MORPHINE SULFATE TABLET [STAT RX USA LLC] | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | MORPHINE SULFATE TABLET [STAT RX USA LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0235 | MORPHINE SULFATE TABLET [HIKMA PHARMACEUTICALS USA INC.] | 11 | Current NDC, Legacy NDC, 3 package rows | 20231219_3c847554-3b4b-4d24-a145-2ef7e9b83699.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 |
|---|
| 0054-0235-24 | 00054023524 | 100 BLISTER PACK in 1 CARTON (0054-0235-24) / 1 TABLET in 1 BLISTER PACK | 100 blister pack | 2008-03-17 | 0000-00-00 | No | No | Current |
| 0054-0235-25 | 00054023525 | 100 TABLET in 1 BOTTLE (0054-0235-25) | 100 tablet | 2008-03-17 | 0000-00-00 | No | No | Current |