fludrocortisone acetate

Generic: fludrocortisone acetate

Labeler: novitium pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fludrocortisone acetate
Generic Name fludrocortisone acetate
Labeler novitium pharma llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fludrocortisone acetate .1 mg/1

Manufacturer
Novitium Pharma LLC

Identifiers & Regulatory

Product NDC 70954-252
Product ID 70954-252_96dbbf53-962b-49a4-a60d-91ae0b9fb9ff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215279
Listing Expiration 2026-12-31
Marketing Start 2022-06-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954252
Hyphenated Format 70954-252

Supplemental Identifiers

RxCUI
313979
UPC
0370954252306
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 ANDA215279 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (70954-252-10)
  • 100 TABLET in 1 BOTTLE (70954-252-20)
  • 500 TABLET in 1 BOTTLE (70954-252-30)
source: ndc

Packages (3)

70954-252-10 30 TABLET in 1 BOTTLE (70954-252-10) 70954-252-20 100 TABLET in 1 BOTTLE (70954-252-20) 70954-252-30 500 TABLET in 1 BOTTLE (70954-252-30)

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": "96dbbf53-962b-49a4-a60d-91ae0b9fb9ff", "openfda": {"upc": ["0370954252306"], "unii": ["V47IF0PVH4"], "rxcui": ["313979"], "spl_set_id": ["96dbbf53-962b-49a4-a60d-91ae0b9fb9ff"], "manufacturer_name": ["Novitium Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (70954-252-10)", "package_ndc": "70954-252-10", "marketing_start_date": "20220602"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (70954-252-20)", "package_ndc": "70954-252-20", "marketing_start_date": "20220602"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70954-252-30)", "package_ndc": "70954-252-30", "marketing_start_date": "20220602"}], "brand_name": "Fludrocortisone Acetate", "product_id": "70954-252_96dbbf53-962b-49a4-a60d-91ae0b9fb9ff", "dosage_form": "TABLET", "product_ndc": "70954-252", "generic_name": "Fludrocortisone Acetate", "labeler_name": "Novitium Pharma LLC", "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": "20220602", "listing_expiration_date": "20261231"}