Morphine sulfate
- Product NDC
- 71335-3080
- 11-digit product format
- 713353080
- Labeler code
- 71335
- Product ID
- 71335-3080_fd13b360-b1b6-4fc5-869a-1a98cd211b5b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- morphine sulfate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078761
- Marketing category
- ANDA
- Marketing start
- 2012-05-11
- Substance
- MORPHINE SULFATE
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X3P646A2J0 |
| Rxcui | 891874 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-3080-1 | Morphine sulfate | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | | 1 |
| 71335-3080-2 | Morphine sulfate | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 1 |
| 71335-3080-3 | Morphine sulfate | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 1 |
| 71335-3080-4 | Morphine sulfate | 120 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 120 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-3080-1 | 71335308001 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-3080-1) | 2026-02-13 | No | No | Historical |
| 71335-3080-2 | 71335308002 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-3080-2) | 2026-02-13 | No | No | Historical |
| 71335-3080-3 | 71335308003 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-3080-3) | 2026-02-13 | No | No | Historical |
| 71335-3080-4 | 71335308004 | 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-3080-4) | 2026-02-13 | No | No | Historical |