fludrocortisone acetate

Generic: fludrocortisone acetate

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fludrocortisone acetate
Generic Name fludrocortisone acetate
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fludrocortisone acetate .1 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-7033
Product ID 0115-7033_1e3aaf68-d0e7-4a70-8ac4-29a9ac4cb037
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040431
Listing Expiration 2026-12-31
Marketing Start 2002-03-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01157033
Hyphenated Format 0115-7033

Supplemental Identifiers

RxCUI
313979
UPC
0301157033027 0301157033010
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 (0115-7033-01)
  • 500 TABLET in 1 BOTTLE (0115-7033-02)
  • 1000 TABLET in 1 BOTTLE (0115-7033-03)
source: ndc

Packages (3)

0115-7033-01 100 TABLET in 1 BOTTLE (0115-7033-01) 0115-7033-02 500 TABLET in 1 BOTTLE (0115-7033-02) 0115-7033-03 1000 TABLET in 1 BOTTLE (0115-7033-03)

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": "1e3aaf68-d0e7-4a70-8ac4-29a9ac4cb037", "openfda": {"upc": ["0301157033027", "0301157033010"], "unii": ["V47IF0PVH4"], "rxcui": ["313979"], "spl_set_id": ["4ed382df-f2d5-46a4-a68b-aba807777093"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0115-7033-01)", "package_ndc": "0115-7033-01", "marketing_start_date": "20020318"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0115-7033-02)", "package_ndc": "0115-7033-02", "marketing_start_date": "20020318"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (0115-7033-03)", "package_ndc": "0115-7033-03", "marketing_start_date": "20020318"}], "brand_name": "Fludrocortisone Acetate", "product_id": "0115-7033_1e3aaf68-d0e7-4a70-8ac4-29a9ac4cb037", "dosage_form": "TABLET", "product_ndc": "0115-7033", "generic_name": "FLUDROCORTISONE ACETATE", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "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": "20020318", "listing_expiration_date": "20261231"}