fludrocortisone acetate

Generic: fludrocortisone acetate

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

fludrocortisone acetate .1 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7317
Product ID 0904-7317_9e36ef12-d8e2-4a21-a1f0-3bc95fe9e557
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215279
Listing Expiration 2026-12-31
Marketing Start 2024-09-04

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047317
Hyphenated Format 0904-7317

Supplemental Identifiers

RxCUI
313979
UNII
V47IF0PVH4

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 ANDA215279 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 CARTON (0904-7317-06) / 1 TABLET in 1 BLISTER PACK
  • 100 BLISTER PACK in 1 CARTON (0904-7317-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

0904-7317-06 50 BLISTER PACK in 1 CARTON (0904-7317-06) / 1 TABLET in 1 BLISTER PACK 0904-7317-61 100 BLISTER PACK in 1 CARTON (0904-7317-61) / 1 TABLET in 1 BLISTER PACK

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": "9e36ef12-d8e2-4a21-a1f0-3bc95fe9e557", "openfda": {"unii": ["V47IF0PVH4"], "rxcui": ["313979"], "spl_set_id": ["933e28ef-05e8-419e-a786-21eab67f33a2"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 CARTON (0904-7317-06)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-7317-06", "marketing_start_date": "20240904"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7317-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-7317-61", "marketing_start_date": "20240904"}], "brand_name": "Fludrocortisone Acetate", "product_id": "0904-7317_9e36ef12-d8e2-4a21-a1f0-3bc95fe9e557", "dosage_form": "TABLET", "product_ndc": "0904-7317", "generic_name": "Fludrocortisone Acetate", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fludrocortisone Acetate", "active_ingredients": [{"name": "FLUDROCORTISONE ACETATE", "strength": ".1 mg/1"}], "application_number": "ANDA215279", "marketing_category": "ANDA", "marketing_start_date": "20240904", "listing_expiration_date": "20261231"}