Morphine Sulfate
- Product NDC
- 62559-170
- 11-digit product format
- 625590170
- Labeler code
- 62559
- Product ID
- 62559-170_16a27365-2e64-4e8f-b46a-3cc41906872d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Morphine Sulfate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA205509
- Marketing category
- ANDA
- Marketing start
- 2018-07-09
- Marketing end
- 2022-07-31
- 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
- 0000-00-00
- 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 62559-170-01 | ML - Milliliter | 62559-170 | 45b959d4-81c1-4df7-b061-452e7d36c6a6 | 1 | 2018-08-13 |
| 62559-170-05 | ML - Milliliter | 62559-170 | 2c385cc7-c4eb-4434-bb78-ba63546cae2c | 1 | 2018-08-13 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 892589 | morphine sulfate 10 MG in 5 mL Oral Solution | PSN | bee55fcb-80a4-45dc-bd10-0127abf7cea0 | 2 |
| 892589 | morphine sulfate 2 MG/ML Oral Solution | SCD | bee55fcb-80a4-45dc-bd10-0127abf7cea0 | 2 |
| 892589 | morphine sulfate 10 MG per 5 ML Oral Solution | SY | bee55fcb-80a4-45dc-bd10-0127abf7cea0 | 2 |
| 892589 | MS 2 MG/ML Oral Solution | SY | bee55fcb-80a4-45dc-bd10-0127abf7cea0 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 62559-170-01 | 62559017001 | 100 mL in 1 BOTTLE (62559-170-01) | 100 ml | 2018-07-09 | 2022-06-30 | No | No | Current |
| 62559-170-05 | 62559017005 | 500 mL in 1 BOTTLE (62559-170-05) | 500 ml | 2018-07-09 | 2022-07-31 | No | No | Current |