fludrocortisone acetate

Generic: fludrocortisone acetate

Labeler: viona pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fludrocortisone acetate
Generic Name fludrocortisone acetate
Labeler viona pharmaceuticals inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fludrocortisone acetate .1 mg/1

Manufacturer
Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-164
Product ID 72578-164_4b107dc9-d932-49db-87ed-66df936588d7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219251
Listing Expiration 2026-12-31
Marketing Start 2024-12-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72578164
Hyphenated Format 72578-164

Supplemental Identifiers

RxCUI
313979
UPC
0372578164010
UNII
V47IF0PVH4

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 fludrocortisone acetate (source: ndc)
Generic Name fludrocortisone acetate (source: ndc)
Application Number ANDA219251 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (72578-164-01)
  • 500 TABLET in 1 BOTTLE (72578-164-05)
source: ndc

Packages (2)

72578-164-01 100 TABLET in 1 BOTTLE (72578-164-01) 72578-164-05 500 TABLET in 1 BOTTLE (72578-164-05)

Ingredients (1)

fludrocortisone acetate (.1 mg/1)

Linked Drug Pages (1)

Fludrocortisone acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4b107dc9-d932-49db-87ed-66df936588d7", "openfda": {"upc": ["0372578164010"], "unii": ["V47IF0PVH4"], "rxcui": ["313979"], "spl_set_id": ["bc92f5c6-3a65-4fab-85b3-fd5b84f917c1"], "manufacturer_name": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (72578-164-01)", "package_ndc": "72578-164-01", "marketing_start_date": "20241202"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (72578-164-05)", "package_ndc": "72578-164-05", "marketing_start_date": "20241202"}], "brand_name": "Fludrocortisone acetate", "product_id": "72578-164_4b107dc9-d932-49db-87ed-66df936588d7", "dosage_form": "TABLET", "product_ndc": "72578-164", "generic_name": "Fludrocortisone acetate", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fludrocortisone acetate", "active_ingredients": [{"name": "FLUDROCORTISONE ACETATE", "strength": ".1 mg/1"}], "application_number": "ANDA219251", "marketing_category": "ANDA", "marketing_start_date": "20241202", "listing_expiration_date": "20261231"}