Morphine Sulfate
- Product NDC
- 68094-556
- 11-digit product format
- 680940556
- Labeler code
- 68094
- Product ID
- 68094-556_c3bf0ba7-1370-4570-b25a-c706c5849988
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Morphine Sulfate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Precision Dose, Inc.
- Application
- NDA022195
- Marketing category
- NDA
- Marketing start
- 2025-09-01
- 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
- 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 | 100 mg/5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | X3P646A2J0 |
| Rxcui | 892625 |
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 |
|---|---|---|---|---|---|---|
| 68094-556-01 | Morphine Sulfate | 0.25 mL in 1 SYRINGE, PLASTIC | SOLUTION | 0.25 | 2 | |
| 68094-556-58 | Morphine Sulfate | 50 in 1 CASE | SOLUTION | 50 | 2 | |
| 68094-556-58 | Morphine Sulfate | 1 in 1 BAG | SOLUTION | 1 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68094-556-01 | EA - Each | 68094-556 | cb00a9f2-af57-471c-a047-c7eb7ce52902 | 1 | 2025-10-14 |
| 68094-556-58 | EA - Each | 68094-556 | d7de99ca-c3da-40cd-9c4f-eb91824a0833 | 1 | 2025-10-14 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 892625 | morphine sulfate 20 MG in 1 mL Concentrate for Oral Solution | PSN | 76966c05-df75-4072-ae99-97e42f91ab75 | 2 |
| 892625 | morphine sulfate 20 MG/ML Oral Solution | SCD | 76966c05-df75-4072-ae99-97e42f91ab75 | 2 |
| 892625 | morphine sulfate 10 MG per 0.5 ML Concentrate for Oral Solution | SY | 76966c05-df75-4072-ae99-97e42f91ab75 | 2 |
| 892625 | morphine sulfate 100 MG per 5 ML Concentrate for Oral Solution | SY | 76966c05-df75-4072-ae99-97e42f91ab75 | 2 |
| 892625 | morphine sulfate 20 MG/ML Concentrate for Oral Solution | SY | 76966c05-df75-4072-ae99-97e42f91ab75 | 2 |
| 892625 | MS 20 MG/ML Oral Solution | SY | 76966c05-df75-4072-ae99-97e42f91ab75 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68094-556-01 | 68094055601 | 0.25 mL in 1 SYRINGE, PLASTIC | 0.25 ml | Historical | |||
| 68094-556-58 | 68094055658 | 50 BAG in 1 CASE (68094-556-58) / 1 SYRINGE, PLASTIC in 1 BAG / .25 mL in 1 SYRINGE, PLASTIC (68094-556-01) | 50 bag | 2025-09-01 | No | No | Historical |