Morphine sulfate
- Product NDC
- 63304-450
- 11-digit product format
- 633040450
- Labeler code
- 63304
- Product ID
- 63304-450_4d15b836-54c7-2f40-e063-6294a90a68a2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- morphine sulfate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA078761
- Marketing category
- ANDA
- Marketing start
- 2012-05-11
- 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 | 891874, 891881, 891888, 891893, 892646 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63304-450-01 | Morphine sulfate | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 13 |
| 63304-450-03 | Morphine sulfate | 10 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 10 | | 13 |
| 63304-450-05 | Morphine sulfate | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MORPHINE SULFATE | ACTIVE INGREDIENT | X3P646A2J0 | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.] | 6 | |
| MORPHINE | ACTIVE MOIETY | 76I7G6D29C | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.] | 6 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.] | 6 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.] | 6 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.] | 6 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.] | 6 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.] | 6 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.] | 6 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.] | 6 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.] | 6 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.] | 6 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.] | 6 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.] | 6 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.] | 6 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.] | 6 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63304-450 | MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 12 | Current NDC, Legacy NDC, 3 package rows | 20231220_736c9b80-682c-4cda-bf18-61b18de0bd39.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63304-450-01 | 63304045001 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-450-01) | 2012-05-11 | 0000-00-00 | No | No | Current |
| 63304-450-03 | 63304045003 | 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-450-03) | 2012-05-11 | 0000-00-00 | No | No | Current |
| 63304-450-05 | 63304045005 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-450-05) | 2012-05-11 | 0000-00-00 | No | No | Current |