abiraterone

Generic: abiraterone acetate

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

Drug Facts

Product Profile

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

abiraterone acetate 500 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-140
Product ID 82009-140_aefba59c-022d-4f26-a6e2-ffea0ab89f26
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210686
Listing Expiration 2026-12-31
Marketing Start 2019-10-07

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 82009140
Hyphenated Format 82009-140

Supplemental Identifiers

RxCUI
1100075 1918042
UPC
0382009140605 0382009139128
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
  • 60 TABLET, FILM COATED in 1 BOTTLE (82009-140-60)
source: ndc

Packages (1)

82009-140-60 60 TABLET, FILM COATED in 1 BOTTLE (82009-140-60)

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": "aefba59c-022d-4f26-a6e2-ffea0ab89f26", "openfda": {"upc": ["0382009140605", "0382009139128"], "unii": ["EM5OCB9YJ6"], "rxcui": ["1100075", "1918042"], "spl_set_id": ["6f5b628b-69da-4a04-a4d5-623b18d1fd5d"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (82009-140-60)", "package_ndc": "82009-140-60", "marketing_start_date": "20240716"}], "brand_name": "Abiraterone", "product_id": "82009-140_aefba59c-022d-4f26-a6e2-ffea0ab89f26", "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": "82009-140", "generic_name": "Abiraterone acetate", "labeler_name": "Quallent Pharmaceuticals Health 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": "20191007", "listing_expiration_date": "20261231"}