abiraterone acetate

Generic: abiraterone acetate

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name abiraterone acetate
Generic Name abiraterone acetate
Labeler apotex corp.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

abiraterone acetate 500 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-4764
Product ID 60505-4764_0b559376-5181-40da-8b69-461bf4d1238e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212462
Listing Expiration 2026-12-31
Marketing Start 2021-07-16

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 605054764
Hyphenated Format 60505-4764

Supplemental Identifiers

RxCUI
1918042
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 ANDA212462 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (60505-4764-6)
source: ndc

Packages (1)

60505-4764-6 60 TABLET, FILM COATED in 1 BOTTLE (60505-4764-6)

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": "0b559376-5181-40da-8b69-461bf4d1238e", "openfda": {"unii": ["EM5OCB9YJ6"], "rxcui": ["1918042"], "spl_set_id": ["9ce9d926-ef3a-4b22-a703-f49c18eb4e3d"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (60505-4764-6)", "package_ndc": "60505-4764-6", "marketing_start_date": "20210716"}], "brand_name": "abiraterone acetate", "product_id": "60505-4764_0b559376-5181-40da-8b69-461bf4d1238e", "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": "60505-4764", "generic_name": "Abiraterone acetate", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "abiraterone acetate", "active_ingredients": [{"name": "ABIRATERONE ACETATE", "strength": "500 mg/1"}], "application_number": "ANDA212462", "marketing_category": "ANDA", "marketing_start_date": "20210716", "listing_expiration_date": "20261231"}