Morphine Sulfate
- Product NDC
- 0641-6191
- 11-digit product format
- 006416191
- Labeler code
- 0641
- Product ID
- 0641-6191_cbc693d6-fa17-4710-b91f-22c4f5d74793
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Morphine Sulfate
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA211452
- Marketing category
- ANDA
- Marketing start
- 2025-04-18
- Substance
- MORPHINE SULFATE
- Active strength
- 2 mg/mL
- 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
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 |
|---|---|---|---|---|---|---|
| 0641-6191-10 | Morphine Sulfate | 1 mL in 1 SYRINGE | INJECTION | 1 | 5 | |
| 0641-6191-10 | Morphine Sulfate | 10 in 1 PACKAGE | INJECTION | 10 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0641-6191-10 | ML - Milliliter | 0641-6191 | cb498cd9-022c-4833-871d-0b5f2afd2fec | 1 | 2025-05-14 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 998212 | morphine sulfate 2 MG in 1 ML Prefilled Syringe | PSN | 69a0d5be-3211-4b7f-962b-e9d9a507321f | 5 |
| 998213 | morphine sulfate 4 MG in 1 ML Prefilled Syringe | PSN | 69a0d5be-3211-4b7f-962b-e9d9a507321f | 5 |
| 998212 | 1 ML morphine sulfate 2 MG/ML Prefilled Syringe | SCD | 69a0d5be-3211-4b7f-962b-e9d9a507321f | 5 |
| 998213 | 1 ML morphine sulfate 4 MG/ML Prefilled Syringe | SCD | 69a0d5be-3211-4b7f-962b-e9d9a507321f | 5 |
| 998212 | 1 ML MS 2 MG/ML Prefilled Syringe | SY | 69a0d5be-3211-4b7f-962b-e9d9a507321f | 5 |
| 998213 | 1 ML MS 4 MG/ML Prefilled Syringe | SY | 69a0d5be-3211-4b7f-962b-e9d9a507321f | 5 |
| 998212 | morphine sulfate 2 MG per 1 ML Prefilled Syringe | SY | 69a0d5be-3211-4b7f-962b-e9d9a507321f | 5 |
| 998213 | morphine sulfate 4 MG per 1 ML Prefilled Syringe | SY | 69a0d5be-3211-4b7f-962b-e9d9a507321f | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0641-6191-10 | 00641619110 | 10 SYRINGE in 1 PACKAGE (0641-6191-10) / 1 mL in 1 SYRINGE | 10 syringe | 2025-04-18 | No | No | Historical |