flunisolide

Generic: flunisolide

Labeler: ingenus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name flunisolide
Generic Name flunisolide
Labeler ingenus pharmaceuticals, llc
Dosage Form SOLUTION
Routes
NASAL
Active Ingredients

flunisolide .25 mg/mL

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-317
Product ID 50742-317_139fb92c-bb10-4ee9-8572-679ac540aa27
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207802
Listing Expiration 2026-12-31
Marketing Start 2022-06-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50742317
Hyphenated Format 50742-317

Supplemental Identifiers

RxCUI
1797863
UNII
QK4DYS664X

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 flunisolide (source: ndc)
Generic Name flunisolide (source: ndc)
Application Number ANDA207802 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (50742-317-25) / 25 mL in 1 BOTTLE, PUMP
source: ndc

Packages (1)

50742-317-25 1 BOTTLE, PUMP in 1 CARTON (50742-317-25) / 25 mL in 1 BOTTLE, PUMP

Ingredients (1)

flunisolide (.25 mg/mL)

Linked Drug Pages (1)

Flunisolide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "139fb92c-bb10-4ee9-8572-679ac540aa27", "openfda": {"unii": ["QK4DYS664X"], "rxcui": ["1797863"], "spl_set_id": ["f39cae46-c68f-47ef-82f3-4fd3dd46c74c"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (50742-317-25)  / 25 mL in 1 BOTTLE, PUMP", "package_ndc": "50742-317-25", "marketing_start_date": "20220623"}], "brand_name": "Flunisolide", "product_id": "50742-317_139fb92c-bb10-4ee9-8572-679ac540aa27", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "50742-317", "generic_name": "Flunisolide", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Flunisolide", "active_ingredients": [{"name": "FLUNISOLIDE", "strength": ".25 mg/mL"}], "application_number": "ANDA207802", "marketing_category": "ANDA", "marketing_start_date": "20220623", "listing_expiration_date": "20261231"}