prednisolone sodium phosphate (0121-4759)

Drug Facts

Product Profile

Brand Name prednisolone sodium phosphate

Generic Name prednisolone sodium phosphate

Labeler pai holdings, llc dba pai pharma

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

prednisolone sodium phosphate 15 mg/5mL

Manufacturer

PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-4759

Product ID 0121-4759_07592713-8b0b-47aa-8a7f-848823ff221c

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA076913

Listing Expiration 2026-12-31

Marketing Start 2024-03-22

Pharmacologic Class

Classes

corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01214759

Hyphenated Format 0121-4759

Supplemental Identifiers

RxCUI

283077

UPC

0301210759086

UNII

IV021NXA9J

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name prednisolone sodium phosphate (source: ndc)

Generic Name prednisolone sodium phosphate (source: ndc)

Application Number ANDA076913 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

15 mg/5mL

source: ndc

Packaging

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)

source: ndc

Packages (1)

0121-4759-50 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)

Ingredients (1)

prednisolone sodium phosphate (15 mg/5mL)

Linked Drug Pages (1)

Prednisolone Sodium Phosphate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "07592713-8b0b-47aa-8a7f-848823ff221c", "openfda": {"upc": ["0301210759086"], "unii": ["IV021NXA9J"], "rxcui": ["283077"], "spl_set_id": ["a0d74ae0-7b2d-4d36-9211-c76f5063b5a9"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "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)", "package_ndc": "0121-4759-50", "marketing_start_date": "20240322"}], "brand_name": "Prednisolone Sodium Phosphate", "product_id": "0121-4759_07592713-8b0b-47aa-8a7f-848823ff221c", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0121-4759", "generic_name": "Prednisolone Sodium Phosphate", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prednisolone Sodium Phosphate", "active_ingredients": [{"name": "PREDNISOLONE SODIUM PHOSPHATE", "strength": "15 mg/5mL"}], "application_number": "ANDA076913", "marketing_category": "ANDA", "marketing_start_date": "20240322", "listing_expiration_date": "20261231"}