Prednisolone Sodium Phosphate
- Product NDC
- 13925-166
- 11-digit product format
- 139250166
- Labeler code
- 13925
- Product ID
- 13925-166_da94c24a-0943-4544-8286-467d7c073c34
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prednisolone Sodium Phosphate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Seton Pharmaceuticals, LLC
- Application
- NDA019157
- Marketing category
- NDA
- Marketing start
- 2013-10-18
- Substance
- PREDNISOLONE SODIUM PHOSPHATE
- Active strength
- 5 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 table| Ingredient | Strength |
|---|
| PREDNISOLONE SODIUM PHOSPHATE | 5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IV021NXA9J |
| Rxcui | 312614 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13925-166-04 | Prednisolone Sodium Phosphate | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PREDNISOLONE SODIUM PHOSPHATE | ACTIVE INGREDIENT | IV021NXA9J | PREDNISOLONE SODIUM PHOSPHATE SOLUTION [SETON PHARMACEUTICALS, LLC] | 3 | |
| PREDNISOLONE | ACTIVE MOIETY | 9PHQ9Y1OLM | PREDNISOLONE SODIUM PHOSPHATE SOLUTION [SETON PHARMACEUTICALS, LLC] | 3 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | PREDNISOLONE SODIUM PHOSPHATE SOLUTION [SETON PHARMACEUTICALS, LLC] | 3 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | PREDNISOLONE SODIUM PHOSPHATE SOLUTION [SETON PHARMACEUTICALS, LLC] | 3 | |
| RASPBERRY | INACTIVE INGREDIENT | 4N14V5R27W | PREDNISOLONE SODIUM PHOSPHATE SOLUTION [SETON PHARMACEUTICALS, LLC] | 3 | |
| SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE | INACTIVE INGREDIENT | 70WT22SF4B | PREDNISOLONE SODIUM PHOSPHATE SOLUTION [SETON PHARMACEUTICALS, LLC] | 3 | |
| SODIUM PHOSPHATE, MONOBASIC | INACTIVE INGREDIENT | 3980JIH2SW | PREDNISOLONE SODIUM PHOSPHATE SOLUTION [SETON PHARMACEUTICALS, LLC] | 3 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | PREDNISOLONE SODIUM PHOSPHATE SOLUTION [SETON PHARMACEUTICALS, LLC] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | PREDNISOLONE SODIUM PHOSPHATE SOLUTION [SETON PHARMACEUTICALS, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13925-166 | PREDNISOLONE SODIUM PHOSPHATE SOLUTION [SETON PHARMACEUTICALS, LLC] | 7 | Current NDC, Legacy NDC, 1 package rows | 20240925_833ba492-8823-43b4-9a91-8b28d94a740b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 13925-166-04 | 13925016604 | 120 mL in 1 BOTTLE (13925-166-04) | 120 ml | 2013-10-18 | 0000-00-00 | No | No | Current |