prednisolone sodium phosphate oral solution

Generic: prednisolone sodium phosphate

Labeler: biocomp pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prednisolone sodium phosphate oral solution
Generic Name prednisolone sodium phosphate
Labeler biocomp pharma, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

prednisolone sodium phosphate 25 mg/5mL

Manufacturer
BioComp Pharma, Inc.

Identifiers & Regulatory

Product NDC 44523-182
Product ID 44523-182_450e8d3f-b6f6-5251-e063-6394a90aa439
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091396
Listing Expiration 2026-12-31
Marketing Start 2019-10-28

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 44523182
Hyphenated Format 44523-182

Supplemental Identifiers

RxCUI
249066
UPC
0344523182080
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 oral solution (source: ndc)
Generic Name prednisolone sodium phosphate (source: ndc)
Application Number ANDA091396 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/5mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE (44523-182-08)
source: ndc

Packages (1)

44523-182-08 237 mL in 1 BOTTLE (44523-182-08)

Ingredients (1)

prednisolone sodium phosphate (25 mg/5mL)

Linked Drug Pages (1)

Prednisolone Sodium Phosphate Oral Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "450e8d3f-b6f6-5251-e063-6394a90aa439", "openfda": {"upc": ["0344523182080"], "unii": ["IV021NXA9J"], "rxcui": ["249066"], "spl_set_id": ["95208441-1700-5d3f-e053-2a95a90a7da2"], "manufacturer_name": ["BioComp Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE (44523-182-08)", "package_ndc": "44523-182-08", "marketing_start_date": "20191028"}], "brand_name": "Prednisolone Sodium Phosphate Oral Solution", "product_id": "44523-182_450e8d3f-b6f6-5251-e063-6394a90aa439", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "44523-182", "generic_name": "Prednisolone Sodium Phosphate", "labeler_name": "BioComp Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prednisolone Sodium Phosphate Oral Solution", "active_ingredients": [{"name": "PREDNISOLONE SODIUM PHOSPHATE", "strength": "25 mg/5mL"}], "application_number": "ANDA091396", "marketing_category": "ANDA", "marketing_start_date": "20191028", "listing_expiration_date": "20261231"}