abiraterone acetate

Generic: abiraterone acetate

Labeler: florida pharmaceutical products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name abiraterone acetate
Generic Name abiraterone acetate
Labeler florida pharmaceutical products, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

abiraterone acetate 500 mg/1

Manufacturer
Florida Pharmaceutical Products, LLC

Identifiers & Regulatory

Product NDC 71921-177
Product ID 71921-177_2b8d3621-3b8b-286c-e063-6294a90a7ac2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215086
Listing Expiration 2026-12-31
Marketing Start 2023-04-10

Pharmacologic Class

Classes
cytochrome p450 17a1 inhibitor [epc] cytochrome p450 17a1 inhibitors [moa] cytochrome p450 2c8 inhibitors [moa] cytochrome p450 2d6 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71921177
Hyphenated Format 71921-177

Supplemental Identifiers

RxCUI
1918042
UPC
0371921177066
UNII
EM5OCB9YJ6

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 abiraterone acetate (source: ndc)
Generic Name abiraterone acetate (source: ndc)
Application Number ANDA215086 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (71921-177-06)
source: ndc

Packages (1)

71921-177-06 60 TABLET, FILM COATED in 1 BOTTLE (71921-177-06)

Ingredients (1)

abiraterone acetate (500 mg/1)

Linked Drug Pages (1)

Abiraterone acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2b8d3621-3b8b-286c-e063-6294a90a7ac2", "openfda": {"upc": ["0371921177066"], "unii": ["EM5OCB9YJ6"], "rxcui": ["1918042"], "spl_set_id": ["68121a71-5024-4f9e-bd9c-2d412f6a6355"], "manufacturer_name": ["Florida Pharmaceutical Products, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71921-177-06)", "package_ndc": "71921-177-06", "marketing_start_date": "20230410"}], "brand_name": "Abiraterone acetate", "product_id": "71921-177_2b8d3621-3b8b-286c-e063-6294a90a7ac2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 17A1 Inhibitor [EPC]", "Cytochrome P450 17A1 Inhibitors [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]"], "product_ndc": "71921-177", "generic_name": "Abiraterone acetate", "labeler_name": "Florida Pharmaceutical Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Abiraterone acetate", "active_ingredients": [{"name": "ABIRATERONE ACETATE", "strength": "500 mg/1"}], "application_number": "ANDA215086", "marketing_category": "ANDA", "marketing_start_date": "20230410", "listing_expiration_date": "20261231"}