Morphine Sulfate
- Product NDC
- 0904-6557
- 11-digit product format
- 009046557
- Labeler code
- 0904
- Product ID
- 0904-6557_a1b7bb1a-5dfd-49bb-acf4-15295726a48f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Morphine Sulfate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA074862
- Marketing category
- ANDA
- Marketing start
- 2011-01-14
- 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
- Brand name suffix
- Extended Release
- 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 | 891874, 891881, 891888, 891893 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-6557-61 | Morphine SulfateExtended Release | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 10 |
| 0904-6557-61 | Morphine SulfateExtended Release | 100 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 100 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6557 | MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240704_dbb37dfd-0196-45f7-b9ca-393f56cf1d28.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 |
|---|
| 0904-6557-61 | 00904655761 | 100 BLISTER PACK in 1 CARTON (0904-6557-61) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 100 blister pack | 2011-01-14 | 0000-00-00 | No | No | Current |