fludrocortisone acetate

Generic: fludrocortisone acetate

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

fludrocortisone acetate .1 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-764
Product ID 42291-764_487504b1-ef26-c343-e063-6294a90a8bf7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040431
Listing Expiration 2027-12-31
Marketing Start 2021-01-13

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291764
Hyphenated Format 42291-764

Supplemental Identifiers

RxCUI
313979
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 ANDA040431 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (42291-764-01)
source: ndc

Packages (1)

42291-764-01 100 TABLET in 1 BOTTLE (42291-764-01)

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": "487504b1-ef26-c343-e063-6294a90a8bf7", "openfda": {"unii": ["V47IF0PVH4"], "rxcui": ["313979"], "spl_set_id": ["b8ce5b7e-7aa2-45f8-e053-2995a90a6c65"], "manufacturer_name": ["AvKARE"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42291-764-01)", "package_ndc": "42291-764-01", "marketing_start_date": "20210113"}], "brand_name": "Fludrocortisone Acetate", "product_id": "42291-764_487504b1-ef26-c343-e063-6294a90a8bf7", "dosage_form": "TABLET", "product_ndc": "42291-764", "generic_name": "FLUDROCORTISONE ACETATE", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fludrocortisone Acetate", "active_ingredients": [{"name": "FLUDROCORTISONE ACETATE", "strength": ".1 mg/1"}], "application_number": "ANDA040431", "marketing_category": "ANDA", "marketing_start_date": "20210113", "listing_expiration_date": "20271231"}