Morphine Sulfate
- Product NDC
- 0054-0404
- 11-digit product format
- 000540404
- Labeler code
- 0054
- Product ID
- 0054-0404_ca359246-4674-4b32-b8b2-673d32b7112f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Morphine Sulfate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA022195
- Marketing category
- NDA
- Marketing start
- 2008-03-17
- Marketing end
- 0000-00-00
- Substance
- MORPHINE SULFATE
- Active strength
- 100 mg/5mL
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|---|---|---|---|---|---|
| 0054-0404-41 | Morphine Sulfate | 15 mL in 1 BOTTLE | SOLUTION | 15 | 4 | |
| 0054-0404-44 | Morphine Sulfate | 30 mL in 1 BOTTLE | SOLUTION | 30 | 4 | |
| 0054-0404-50 | Morphine Sulfate | 120 mL in 1 BOTTLE | SOLUTION | 120 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0054-0404-41 | ML - Milliliter | 0054-0404 | df083984-2fc2-4a48-aa16-7a3c942ec370 | 1 | 2012-07-24 |
| 0054-0404-44 | ML - Milliliter | 0054-0404 | 3c370735-f78a-4ca0-93ca-48deeae62301 | 1 | 2012-07-24 |
| 0054-0404-50 | ML - Milliliter | 0054-0404 | 01c8468f-6136-4b82-bc39-e6ee845f1afd | 1 | 2012-07-24 |
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 | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 892625 | morphine sulfate 20 MG in 1 mL Concentrate for Oral Solution | PSN | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 894780 | morphine sulfate 20 MG in 5 mL Oral Solution | PSN | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 892589 | morphine sulfate 2 MG/ML Oral Solution | SCD | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 892625 | morphine sulfate 20 MG/ML Oral Solution | SCD | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 894780 | morphine sulfate 4 MG/ML Oral Solution | SCD | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 892625 | morphine sulfate 10 MG per 0.5 ML Concentrate for Oral Solution | SY | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 892589 | morphine sulfate 10 MG per 5 ML Oral Solution | SY | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 892625 | morphine sulfate 100 MG per 5 ML Concentrate for Oral Solution | SY | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 894780 | morphine sulfate 20 MG per 5 ML Oral Solution | SY | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 892625 | morphine sulfate 20 MG/ML Concentrate for Oral Solution | SY | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 892589 | MS 2 MG/ML Oral Solution | SY | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 892625 | MS 20 MG/ML Oral Solution | SY | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
| 894780 | MS 4 MG/ML Oral Solution | SY | ca359246-4674-4b32-b8b2-673d32b7112f | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0054-0404-41 | 00054040441 | 15 mL in 1 BOTTLE (0054-0404-41) | 15 ml | 2011-05-24 | 0000-00-00 | No | No | Current |
| 0054-0404-44 | 00054040444 | 30 mL in 1 BOTTLE (0054-0404-44) | 30 ml | 2010-01-25 | 0000-00-00 | No | No | Current |
| 0054-0404-50 | 00054040450 | 120 mL in 1 BOTTLE (0054-0404-50) | 120 ml | 2010-01-25 | 0000-00-00 | No | No | Current |