Prednisolone Sodium Phosphate
- Product NDC
- 50436-0759
- 11-digit product format
- 504360759
- Labeler code
- 50436
- Product ID
- 50436-0759_2bed9ec8-f2fd-4b38-bd97-8a1ef95316c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prednisolone Sodium Phosphate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA076913
- Marketing category
- ANDA
- Marketing start
- 2005-04-25
- Marketing end
- 0000-00-00
- Substance
- PREDNISOLONE SODIUM PHOSPHATE
- Active strength
- 15 mg/5mL
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b3fecff3-fb51-4f66-b443-a130905bb500 | Product name | 1 | 20250804 |
| 3a7a0034-a88d-88c3-f43e-ea34c6a216de | Product name | 2 | 20250311 |
| efd58dcf-540a-4531-8766-e713129ca6f2 | Product name | 1 | 20250307 |
| 4b7700e3-6e0e-45e5-9d22-6f754d61386e | Product name | 2 | 20250304 |
| 9dbc4744-f7be-4393-b71a-e1bfd8b97659 | Product name | 2 | 20250218 |
| 9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5 | Product name | 2 | 20240102 |
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553a | Product name | 1 | 20170309 |
| af7d3306-1338-423f-839e-419aad9e8a86 | Product name | 1 | 20170309 |
| 18d57d04-4a34-a130-5dd5-b7fc47f3b567 | Product name | 1 | 20140508 |
| 379bc253-901a-e6e1-92b7-0fc574249e07 | Product name | 1 | 20140508 |
| 48b05f5d-d2fc-45ab-76e8-3cb5bd44890d | Product name | 1 | 20140508 |
| 73adedd8-aba8-27d9-78d9-2e3c4a3cf954 | Product name | 1 | 20140508 |
| 9ae74339-0a3d-82e9-5dd1-88bd2607bd6b | Product name | 1 | 20140508 |
| 9f10552a-9a7b-8e6c-3223-dc44310af6cf | Product name | 1 | 20140508 |
| e44e38a9-2d9e-b0e2-cce9-490554639f3d | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50436-0759-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2009-a910-e053-dadaa90a0b85 | PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION (15 mg Prednisolone Base per 5 mL) |
| 50436-0759-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2009-a910-e053-dadaa90a0b85 | PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION (15 mg Prednisolone Base per 5 mL) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-0759-1 | Prednisolone Sodium Phosphate | 5 mL in 1 CUP | SOLUTION | 5 | 4 | |
| 50436-0759-2 | Prednisolone Sodium Phosphate | 30 mL in 1 CUP | SOLUTION | 30 | 4 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-0759 | PREDNISOLONE SODIUM PHOSPHATE SOLUTION [UNIT DOSE SERVICES] | 4 | Legacy NDC, 2 package rows | 20191114_06caccd6-07df-4ca5-a5ca-3564bde3192a.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 283077 | prednisoLONE sodium phosphate 15 MG in 5 mL Oral Solution | PSN | 06caccd6-07df-4ca5-a5ca-3564bde3192a | 4 |
| 283077 | prednisolone 3 MG/ML Oral Solution | SCD | 06caccd6-07df-4ca5-a5ca-3564bde3192a | 4 |
| 283077 | prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral Solution | SY | 06caccd6-07df-4ca5-a5ca-3564bde3192a | 4 |
| 283077 | prednisolone 15 MG per 5 ML Oral Solution | SY | 06caccd6-07df-4ca5-a5ca-3564bde3192a | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 50436-0759-1 | 50436075901 | 5 mL in 1 CUP | 5 ml | Historical |
| 50436-0759-2 | 50436075902 | 30 mL in 1 CUP | 30 ml | Historical |