Morphine Sulfate
- Product NDC
- 43386-540
- 11-digit product format
- 433860540
- Labeler code
- 43386
- Product ID
- 43386-540_d4efe614-fe99-4cc7-b3ba-87c4e010efbd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Morphine Sulfate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA203602
- Marketing category
- ANDA
- Marketing start
- 2015-12-16
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Morphine Sulfate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MORPHINE SULFATE | 15 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 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 944b0689-73f4-6a2f-c654-1180896353c0 | Product name | 4 | 20220210 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 67e166c6-23d4-4709-b77d-5ca6182dcae0 | Product name | 1 | 20180830 |
| c573a64c-fe17-2eac-fbcb-788868b4ff6b | Product name | 9 | 20180619 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 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 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| 4c272b1c-87fc-ebc0-994d-ac28b1e0416e | Product name | 1 | 20140508 |
| 7a537f54-d322-5e54-a3a2-035d3e21c3c6 | Product name | 1 | 20140508 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43386-540-01 | Morphine Sulfate | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | 7 | |
| 43386-540-05 | Morphine Sulfate | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | 7 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 891874 | morphine sulfate 100 MG Extended Release Oral Tablet | PSN | d360a33f-6323-4b10-9e81-07e2813c2dbd | 7 |
| 891881 | morphine sulfate 15 MG Extended Release Oral Tablet | PSN | d360a33f-6323-4b10-9e81-07e2813c2dbd | 7 |
| 892646 | morphine sulfate 200 MG Extended Release Oral Tablet | PSN | d360a33f-6323-4b10-9e81-07e2813c2dbd | 7 |
| 891888 | morphine sulfate 30 MG Extended Release Oral Tablet | PSN | d360a33f-6323-4b10-9e81-07e2813c2dbd | 7 |
| 891893 | morphine sulfate 60 MG Extended Release Oral Tablet | PSN | d360a33f-6323-4b10-9e81-07e2813c2dbd | 7 |
| 891874 | morphine sulfate 100 MG Extended Release Oral Tablet | SCD | d360a33f-6323-4b10-9e81-07e2813c2dbd | 7 |
| 891881 | morphine sulfate 15 MG Extended Release Oral Tablet | SCD | d360a33f-6323-4b10-9e81-07e2813c2dbd | 7 |
| 892646 | morphine sulfate 200 MG Extended Release Oral Tablet | SCD | d360a33f-6323-4b10-9e81-07e2813c2dbd | 7 |
| 891888 | morphine sulfate 30 MG Extended Release Oral Tablet | SCD | d360a33f-6323-4b10-9e81-07e2813c2dbd | 7 |
| 891893 | morphine sulfate 60 MG Extended Release Oral Tablet | SCD | d360a33f-6323-4b10-9e81-07e2813c2dbd | 7 |
| 891874 | MS 100 MG Extended Release Oral Tablet | SY | d360a33f-6323-4b10-9e81-07e2813c2dbd | 7 |
| 891881 | MS 15 MG Extended Release Oral Tablet | SY | d360a33f-6323-4b10-9e81-07e2813c2dbd | 7 |
| 892646 | MS 200 MG Extended Release Oral Tablet | SY | d360a33f-6323-4b10-9e81-07e2813c2dbd | 7 |
| 891888 | MS 30 MG Extended Release Oral Tablet | SY | d360a33f-6323-4b10-9e81-07e2813c2dbd | 7 |
| 891893 | MS 60 MG Extended Release Oral Tablet | SY | d360a33f-6323-4b10-9e81-07e2813c2dbd | 7 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 43386-540-01 | 43386054001 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43386-540-01) | 2015-12-16 | 0000-00-00 | No | No | Current |
| 43386-540-05 | 43386054005 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43386-540-05) | 2015-12-16 | 0000-00-00 | No | No | Current |