prednisolone sodium phosphate (13925-166)

Drug Facts

Product Profile

Brand Name prednisolone sodium phosphate

Generic Name prednisolone sodium phosphate

Labeler seton pharmaceuticals, llc

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

prednisolone sodium phosphate 5 mg/5mL

Manufacturer

Seton Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 13925-166

Product ID 13925-166_da94c24a-0943-4544-8286-467d7c073c34

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA

Application Number NDA019157

Listing Expiration 2026-12-31

Marketing Start 2013-10-18

Pharmacologic Class

Classes

corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13925166

Hyphenated Format 13925-166

Supplemental Identifiers

RxCUI

312614

UPC

0313925166042

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 NDA019157 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/5mL

source: ndc

Packaging

120 mL in 1 BOTTLE (13925-166-04)

source: ndc

Packages (1)

13925-166-04 120 mL in 1 BOTTLE (13925-166-04)

Ingredients (1)

prednisolone sodium phosphate (5 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": "da94c24a-0943-4544-8286-467d7c073c34", "openfda": {"upc": ["0313925166042"], "unii": ["IV021NXA9J"], "rxcui": ["312614"], "spl_set_id": ["833ba492-8823-43b4-9a91-8b28d94a740b"], "manufacturer_name": ["Seton Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (13925-166-04)", "package_ndc": "13925-166-04", "marketing_start_date": "20131018"}], "brand_name": "Prednisolone Sodium Phosphate", "product_id": "13925-166_da94c24a-0943-4544-8286-467d7c073c34", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "13925-166", "generic_name": "Prednisolone Sodium Phosphate", "labeler_name": "Seton Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prednisolone Sodium Phosphate", "active_ingredients": [{"name": "PREDNISOLONE SODIUM PHOSPHATE", "strength": "5 mg/5mL"}], "application_number": "NDA019157", "marketing_category": "NDA", "marketing_start_date": "20131018", "listing_expiration_date": "20261231"}