prednisolone sodium phosphate odt

Generic: prednisolone sodium phosphate

Labeler: ingenus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name prednisolone sodium phosphate odt
Generic Name prednisolone sodium phosphate
Labeler ingenus pharmaceuticals, llc
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

prednisolone sodium phosphate 15 mg/1

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-384
Product ID 50742-384_ebbc1751-9381-4db1-89ff-ae5a2963fb2c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021959
Listing Expiration 2026-12-31
Marketing Start 2025-09-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50742384
Hyphenated Format 50742-384

Supplemental Identifiers

RxCUI
643123 643125 643127
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 odt (source: ndc)
Generic Name prednisolone sodium phosphate (source: ndc)
Application Number NDA021959 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (50742-384-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (50742-384-06)
source: ndc

Packages (1)

50742-384-12 2 BLISTER PACK in 1 CARTON (50742-384-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (50742-384-06)

Ingredients (1)

prednisolone sodium phosphate (15 mg/1)

Linked Drug Pages (1)

prednisolone sodium phosphate ODT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ebbc1751-9381-4db1-89ff-ae5a2963fb2c", "openfda": {"unii": ["IV021NXA9J"], "rxcui": ["643123", "643125", "643127"], "spl_set_id": ["ebbc1751-9381-4db1-89ff-ae5a2963fb2c"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50742-384-12)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (50742-384-06)", "package_ndc": "50742-384-12", "marketing_start_date": "20250915"}], "brand_name": "prednisolone sodium phosphate ODT", "product_id": "50742-384_ebbc1751-9381-4db1-89ff-ae5a2963fb2c", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "50742-384", "generic_name": "prednisolone sodium phosphate", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "prednisolone sodium phosphate", "brand_name_suffix": "ODT", "active_ingredients": [{"name": "PREDNISOLONE SODIUM PHOSPHATE", "strength": "15 mg/1"}], "application_number": "NDA021959", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20250915", "listing_expiration_date": "20261231"}