Prednisolone Sodium Phosphate
- Product NDC
- 68788-4046
- 11-digit product format
- 687884046
- Labeler code
- 68788
- Product ID
- 68788-4046_7262fc84-3db2-4475-8ae4-6bec4477cb81
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prednisolone Sodium Phosphate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA203559
- Marketing category
- ANDA
- Marketing start
- 2025-10-28
- Substance
- PREDNISOLONE SODIUM PHOSPHATE
- Active strength
- 15 mg/5mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Prednisolone Sodium Phosphate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PREDNISOLONE SODIUM PHOSPHATE | 15 mg/5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | IV021NXA9J |
| Rxcui | 283077 |
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 |
| 9dbc4744-f7be-4393-b71a-e1bfd8b97659 | Product name | 2 | 20250218 |
| 9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5 | Product name | 2 | 20240102 |
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68788-4046-2 | Prednisolone Sodium Phosphate | 237 mL in 1 BOTTLE, PLASTIC | SOLUTION | 237 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-4046-2 | ML - Milliliter | 68788-4046 | 85a5fa9f-2927-43aa-838b-ddd75e17f649 | 1 | 2026-03-17 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 283077 | prednisoLONE sodium phosphate 15 MG in 5 mL Oral Solution | PSN | 7262fc84-3db2-4475-8ae4-6bec4477cb81 | 1 |
| 283077 | prednisolone 3 MG/ML Oral Solution | SCD | 7262fc84-3db2-4475-8ae4-6bec4477cb81 | 1 |
| 283077 | prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral Solution | SY | 7262fc84-3db2-4475-8ae4-6bec4477cb81 | 1 |
| 283077 | prednisolone 15 MG per 5 ML Oral Solution | SY | 7262fc84-3db2-4475-8ae4-6bec4477cb81 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68788-4046-2 | 68788404602 | 237 mL in 1 BOTTLE, PLASTIC (68788-4046-2) | 237 ml | 2025-10-28 | No | No | Current |