Prednisolone Sodium Phosphate
- Product NDC
- 0121-4759
- 11-digit product format
- 001214759
- Labeler code
- 0121
- Product ID
- 0121-4759_07592713-8b0b-47aa-8a7f-848823ff221c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prednisolone Sodium Phosphate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA076913
- Marketing category
- ANDA
- Marketing start
- 2024-03-22
- 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 table| Ingredient | Strength |
|---|
| PREDNISOLONE SODIUM PHOSPHATE | 15 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IV021NXA9J |
| Rxcui | 283077 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0121-4759-05 | Prednisolone Sodium Phosphate | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | | 16 |
| 0121-4759-50 | Prednisolone Sodium Phosphate | 10 in 1 TRAY | SOLUTION | 10 | | 16 |
| 0121-4759-50 | Prednisolone Sodium Phosphate | 5 in 1 CASE | SOLUTION | 5 | | 16 |
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 [PHARMACEUTICAL ASSOCIATES, INC.] | 3 | |
| Prednisolone | ACTIVE MOIETY | 9PHQ9Y1OLM | PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 3 | |
| Corn Syrup | INACTIVE INGREDIENT | 9G5L16BK6N | PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 3 | |
| Edetate Disodium | INACTIVE INGREDIENT | 7FLD91C86K | PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 3 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 3 | |
| Hydroxyethyl Cellulose (140 MPA.S at 5%) | INACTIVE INGREDIENT | 8136Y38GY5 | PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 3 | |
| Methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 3 | |
| Potassium Phosphate, Dibasic | INACTIVE INGREDIENT | CI71S98N1Z | PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 3 | |
| Potassium Phosphate, Monobasic | INACTIVE INGREDIENT | 4J9FJ0HL51 | PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 3 | |
| Saccharin Sodium Dihydrate | INACTIVE INGREDIENT | SB8ZUX40TY | PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 3 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-4759 | PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 14 | Current NDC, 3 package rows | 20240820_a0d74ae0-7b2d-4d36-9211-c76f5063b5a9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0121-4759-05 | 00121475905 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | Historical |
| 0121-4759-50 | 00121475950 | 5 TRAY in 1 CASE (0121-4759-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4759-05) | 5 tray | 2024-03-22 | No | No | Historical |