Morphine sulfate
- Product NDC
- 63304-452
- 11-digit product format
- 633040452
- Labeler code
- 63304
- Product ID
- 63304-452_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
- 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 |
|---|---|
| MORPHINE SULFATE | 100 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | X3P646A2J0 |
| Rxcui | 891874, 891881, 891888, 891893, 892646 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 89941d4c-522d-cee0-b273-43cfa7ef6d35 | Product name | 4 | 20250516 |
| f15f9e76-db42-8a50-218a-5ef5affa58da | Product name | 4 | 20240216 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 944b0689-73f4-6a2f-c654-1180896353c0 | Product name | 4 | 20220210 |
| 67e166c6-23d4-4709-b77d-5ca6182dcae0 | Product name | 1 | 20180830 |
| c573a64c-fe17-2eac-fbcb-788868b4ff6b | Product name | 9 | 20180619 |
| 7c1819cf-69a0-41dc-aeaa-a820729bc959 | Product name | 1 | 20170406 |
| 7a68fc31-10e5-df04-67e0-3a613a2d4d2e | Product name | 5 | 20161114 |
| 175682a8-c657-45a2-9dfb-c565306b03c8 | Product name | 1 | 20160112 |
| b73dadd0-1b4a-4f88-956f-a2be216c8fad | Product name | 1 | 20151123 |
| 4c272b1c-87fc-ebc0-994d-ac28b1e0416e | Product name | 1 | 20140508 |
| 7a537f54-d322-5e54-a3a2-035d3e21c3c6 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63304-452-01 | Morphine sulfate | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | 13 | |
| 63304-452-03 | Morphine sulfate | 10 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 10 | 13 | |
| 63304-452-05 | Morphine sulfate | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | 13 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 891874 | morphine sulfate 100 MG Extended Release Oral Tablet | PSN | 3a89d0ca-4ff8-4bdc-8ea8-9ad591ce7226 | 103 |
| 891874 | morphine sulfate 100 MG Extended Release Oral Tablet | SCD | 3a89d0ca-4ff8-4bdc-8ea8-9ad591ce7226 | 103 |
| 891874 | MS 100 MG Extended Release Oral Tablet | SY | 3a89d0ca-4ff8-4bdc-8ea8-9ad591ce7226 | 103 |
| 891874 | morphine sulfate 100 MG Extended Release Oral Tablet | PSN | 736c9b80-682c-4cda-bf18-61b18de0bd39 | 13 |
| 891881 | morphine sulfate 15 MG Extended Release Oral Tablet | PSN | 736c9b80-682c-4cda-bf18-61b18de0bd39 | 13 |
| 892646 | morphine sulfate 200 MG Extended Release Oral Tablet | PSN | 736c9b80-682c-4cda-bf18-61b18de0bd39 | 13 |
| 891888 | morphine sulfate 30 MG Extended Release Oral Tablet | PSN | 736c9b80-682c-4cda-bf18-61b18de0bd39 | 13 |
| 891893 | morphine sulfate 60 MG Extended Release Oral Tablet | PSN | 736c9b80-682c-4cda-bf18-61b18de0bd39 | 13 |
| 891874 | morphine sulfate 100 MG Extended Release Oral Tablet | SCD | 736c9b80-682c-4cda-bf18-61b18de0bd39 | 13 |
| 891881 | morphine sulfate 15 MG Extended Release Oral Tablet | SCD | 736c9b80-682c-4cda-bf18-61b18de0bd39 | 13 |
| 892646 | morphine sulfate 200 MG Extended Release Oral Tablet | SCD | 736c9b80-682c-4cda-bf18-61b18de0bd39 | 13 |
| 891888 | morphine sulfate 30 MG Extended Release Oral Tablet | SCD | 736c9b80-682c-4cda-bf18-61b18de0bd39 | 13 |
| 891893 | morphine sulfate 60 MG Extended Release Oral Tablet | SCD | 736c9b80-682c-4cda-bf18-61b18de0bd39 | 13 |
| 891874 | MS 100 MG Extended Release Oral Tablet | SY | 736c9b80-682c-4cda-bf18-61b18de0bd39 | 13 |
| 891881 | MS 15 MG Extended Release Oral Tablet | SY | 736c9b80-682c-4cda-bf18-61b18de0bd39 | 13 |
| 892646 | MS 200 MG Extended Release Oral Tablet | SY | 736c9b80-682c-4cda-bf18-61b18de0bd39 | 13 |
| 891888 | MS 30 MG Extended Release Oral Tablet | SY | 736c9b80-682c-4cda-bf18-61b18de0bd39 | 13 |
| 891893 | MS 60 MG Extended Release Oral Tablet | SY | 736c9b80-682c-4cda-bf18-61b18de0bd39 | 13 |
| 891874 | morphine sulfate 100 MG Extended Release Oral Tablet | PSN | 07993f6c-146b-4728-a2da-6e93089f78ff | 1 |
| 891874 | morphine sulfate 100 MG Extended Release Oral Tablet | SCD | 07993f6c-146b-4728-a2da-6e93089f78ff | 1 |
| 891874 | MS 100 MG Extended Release Oral Tablet | SY | 07993f6c-146b-4728-a2da-6e93089f78ff | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63304-452-01 | 63304045201 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-452-01) | 2012-05-11 | 0000-00-00 | No | No | Current |
| 63304-452-03 | 63304045203 | 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-452-03) | 2012-05-11 | 0000-00-00 | No | No | Current |
| 63304-452-05 | 63304045205 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-452-05) | 2012-05-11 | 0000-00-00 | No | No | Current |