Morphine Sulfate
- Product NDC
- 75826-129
- 11-digit product format
- 758260129
- Labeler code
- 75826
- Product ID
- 75826-129_2b0eba4c-7f43-72ef-e063-6294a90afd7e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Morphine Sulfate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Winder Laboratories LLC
- Application
- ANDA211454
- Marketing category
- ANDA
- Marketing start
- 2019-05-15
- Substance
- MORPHINE SULFATE
- Active strength
- 10 mg/5mL
- 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 | 10 mg/5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | X3P646A2J0 |
| Rxcui | 892589, 892625, 894780 |
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 |
| 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 |
|---|---|---|---|---|---|---|
| 75826-129-05 | Morphine Sulfate | 100 mL in 1 BOTTLE, PLASTIC | SOLUTION | 100 | 8 | |
| 75826-129-17 | Morphine Sulfate | 500 mL in 1 BOTTLE, PLASTIC | SOLUTION | 500 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 75826-129-05 | ML - Milliliter | 75826-129 | b07d0bc1-1dc4-4b4a-b18d-b97f1b815d0e | 1 | 2024-06-10 |
| 75826-129-17 | ML - Milliliter | 75826-129 | e2c17999-3a3e-4b00-9eeb-d9fb9b97e49c | 1 | 2024-06-10 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 892589 | morphine sulfate 10 MG in 5 mL Oral Solution | PSN | e9a7319a-bf1f-48db-a71e-6d4e6ead9555 | 8 |
| 892625 | morphine sulfate 20 MG in 1 mL Concentrate for Oral Solution | PSN | e9a7319a-bf1f-48db-a71e-6d4e6ead9555 | 8 |
| 894780 | morphine sulfate 20 MG in 5 mL Oral Solution | PSN | e9a7319a-bf1f-48db-a71e-6d4e6ead9555 | 8 |
| 892589 | morphine sulfate 2 MG/ML Oral Solution | SCD | e9a7319a-bf1f-48db-a71e-6d4e6ead9555 | 8 |
| 892625 | morphine sulfate 20 MG/ML Oral Solution | SCD | e9a7319a-bf1f-48db-a71e-6d4e6ead9555 | 8 |
| 894780 | morphine sulfate 4 MG/ML Oral Solution | SCD | e9a7319a-bf1f-48db-a71e-6d4e6ead9555 | 8 |
| 892625 | morphine sulfate 10 MG per 0.5 ML Concentrate for Oral Solution | SY | e9a7319a-bf1f-48db-a71e-6d4e6ead9555 | 8 |
| 892589 | morphine sulfate 10 MG per 5 ML Oral Solution | SY | e9a7319a-bf1f-48db-a71e-6d4e6ead9555 | 8 |
| 892625 | morphine sulfate 100 MG per 5 ML Concentrate for Oral Solution | SY | e9a7319a-bf1f-48db-a71e-6d4e6ead9555 | 8 |
| 894780 | morphine sulfate 20 MG per 5 ML Oral Solution | SY | e9a7319a-bf1f-48db-a71e-6d4e6ead9555 | 8 |
| 892625 | morphine sulfate 20 MG/ML Concentrate for Oral Solution | SY | e9a7319a-bf1f-48db-a71e-6d4e6ead9555 | 8 |
| 892589 | MS 2 MG/ML Oral Solution | SY | e9a7319a-bf1f-48db-a71e-6d4e6ead9555 | 8 |
| 892625 | MS 20 MG/ML Oral Solution | SY | e9a7319a-bf1f-48db-a71e-6d4e6ead9555 | 8 |
| 894780 | MS 4 MG/ML Oral Solution | SY | e9a7319a-bf1f-48db-a71e-6d4e6ead9555 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 75826-129-05 | 75826012905 | 100 mL in 1 BOTTLE, PLASTIC (75826-129-05) | 100 ml | 2019-05-15 | 0000-00-00 | No | No | Current |
| 75826-129-10 | 75826012910 | 100 mL in 1 BOTTLE, PLASTIC (75826-129-10) | 100 ml | 2021-02-25 | 0000-00-00 | No | No | Current |
| 75826-129-17 | 75826012917 | 500 mL in 1 BOTTLE, PLASTIC (75826-129-17) | 500 ml | 2019-05-15 | 0000-00-00 | No | No | Current |
| 75826-129-50 | 75826012950 | 500 mL in 1 BOTTLE, PLASTIC (75826-129-50) | 500 ml | 2021-02-25 | 0000-00-00 | No | No | Current |