fludrocortisone acetate

Generic: fludrocortisone acetate

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fludrocortisone acetate
Generic Name fludrocortisone acetate
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fludrocortisone acetate .1 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-288
Product ID 68084-288_35818f71-8d18-1daa-e063-6394a90aeb9f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040431
Listing Expiration 2026-12-31
Marketing Start 2008-09-05

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68084288
Hyphenated Format 68084-288

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 ANDA040431 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-288-01) / 1 TABLET in 1 BLISTER PACK (68084-288-11)
  • 50 BLISTER PACK in 1 CARTON (68084-288-65) / 1 TABLET in 1 BLISTER PACK (68084-288-11)
source: ndc

Packages (2)

68084-288-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-288-01) / 1 TABLET in 1 BLISTER PACK (68084-288-11) 68084-288-65 50 BLISTER PACK in 1 CARTON (68084-288-65) / 1 TABLET in 1 BLISTER PACK (68084-288-11)

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": "35818f71-8d18-1daa-e063-6394a90aeb9f", "openfda": {"unii": ["V47IF0PVH4"], "rxcui": ["313979"], "spl_set_id": ["001e72ea-2c9e-468c-90cc-6c347234e2a9"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-288-01)  / 1 TABLET in 1 BLISTER PACK (68084-288-11)", "package_ndc": "68084-288-01", "marketing_start_date": "20080905"}, {"sample": false, "description": "50 BLISTER PACK in 1 CARTON (68084-288-65)  / 1 TABLET in 1 BLISTER PACK (68084-288-11)", "package_ndc": "68084-288-65", "marketing_start_date": "20230209"}], "brand_name": "Fludrocortisone Acetate", "product_id": "68084-288_35818f71-8d18-1daa-e063-6394a90aeb9f", "dosage_form": "TABLET", "product_ndc": "68084-288", "generic_name": "Fludrocortisone Acetate", "labeler_name": "American Health Packaging", "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": "20080905", "listing_expiration_date": "20261231"}