Morphine Sulfate
- Product NDC
- 0121-4955
- 11-digit product format
- 001214955
- Labeler code
- 0121
- Product ID
- 0121-4955_8a1bb0fe-ab24-4c30-b843-d06c61fcf0cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MORPHINE SULFATE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA206573
- Marketing category
- ANDA
- Marketing start
- 2025-09-15
- 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
- 2027-12-31
- 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 |
|---|---|---|---|---|---|---|
| 0121-4955-05 | Morphine Sulfate | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | 21 | |
| 0121-4955-94 | Morphine Sulfate | 10 in 1 TRAY | SOLUTION | 10 | 21 | |
| 0121-4955-94 | Morphine Sulfate | 3 in 1 CASE | SOLUTION | 3 | 21 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0121-4955-05 | ML - Milliliter | 0121-4955 | e4eb7b85-2cd8-4334-b134-e17a8f2cd3fe | 1 | 2025-10-14 |
| 0121-4955-94 | ML - Milliliter | 0121-4955 | 62e80bbd-fb6c-4fd3-a975-60ef0c3851b3 | 1 | 2025-10-14 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 892589 | morphine sulfate 10 MG in 5 mL Oral Solution | PSN | 9405556c-20e0-4e47-b1b0-7872bcc6517e | 21 |
| 892589 | morphine sulfate 2 MG/ML Oral Solution | SCD | 9405556c-20e0-4e47-b1b0-7872bcc6517e | 21 |
| 892589 | morphine sulfate 10 MG per 5 ML Oral Solution | SY | 9405556c-20e0-4e47-b1b0-7872bcc6517e | 21 |
| 892589 | MS 2 MG/ML Oral Solution | SY | 9405556c-20e0-4e47-b1b0-7872bcc6517e | 21 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0121-4955-05 | 00121495505 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | Historical | |||
| 0121-4955-94 | 00121495594 | 3 TRAY in 1 CASE (0121-4955-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4955-05) | 3 tray | 2025-09-15 | No | No | Historical |