abiraterone

Generic: abiraterone acetate

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name abiraterone
Generic Name abiraterone acetate
Labeler novadoz pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

abiraterone acetate 500 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-285
Product ID 72205-285_a87a3fa5-28cb-42be-9039-af800a7c482c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210686
Listing Expiration 2026-12-31
Marketing Start 2024-04-24

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 72205285
Hyphenated Format 72205-285

Supplemental Identifiers

RxCUI
1100075 1918042
UPC
0372205284050 0372205284920 0372205030923 0372205285057 0372205285606
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 (source: ndc)
Generic Name abiraterone acetate (source: ndc)
Application Number ANDA210686 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (72205-285-05)
  • 60 TABLET, FILM COATED in 1 BOTTLE (72205-285-60)
source: ndc

Packages (2)

72205-285-05 500 TABLET, FILM COATED in 1 BOTTLE (72205-285-05) 72205-285-60 60 TABLET, FILM COATED in 1 BOTTLE (72205-285-60)

Ingredients (1)

abiraterone acetate (500 mg/1)

Linked Drug Pages (1)

Abiraterone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a87a3fa5-28cb-42be-9039-af800a7c482c", "openfda": {"upc": ["0372205284050", "0372205284920", "0372205030923", "0372205285057", "0372205285606"], "unii": ["EM5OCB9YJ6"], "rxcui": ["1100075", "1918042"], "spl_set_id": ["88d05db3-8bdc-47f1-bb00-6b4a71f98609"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (72205-285-05)", "package_ndc": "72205-285-05", "marketing_start_date": "20240524"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (72205-285-60)", "package_ndc": "72205-285-60", "marketing_start_date": "20240524"}], "brand_name": "Abiraterone", "product_id": "72205-285_a87a3fa5-28cb-42be-9039-af800a7c482c", "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": "72205-285", "generic_name": "Abiraterone acetate", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Abiraterone", "active_ingredients": [{"name": "ABIRATERONE ACETATE", "strength": "500 mg/1"}], "application_number": "ANDA210686", "marketing_category": "ANDA", "marketing_start_date": "20240424", "listing_expiration_date": "20261231"}