abiraterone

Generic: abiraterone acetate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name abiraterone
Generic Name abiraterone acetate
Labeler hikma pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

abiraterone acetate 250 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9597
Product ID 0143-9597_35e5846f-9299-4190-94bb-6b0bb0d92485
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208339
Listing Expiration 2026-12-31
Marketing Start 2018-11-23

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 01439597
Hyphenated Format 0143-9597

Supplemental Identifiers

RxCUI
1100075
UPC
0301439597216
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 ANDA208339 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 120 TABLET in 1 BOTTLE (0143-9597-21)
source: ndc

Packages (1)

0143-9597-21 120 TABLET in 1 BOTTLE (0143-9597-21)

Ingredients (1)

abiraterone acetate (250 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": "35e5846f-9299-4190-94bb-6b0bb0d92485", "openfda": {"upc": ["0301439597216"], "unii": ["EM5OCB9YJ6"], "rxcui": ["1100075"], "spl_set_id": ["be29365a-ed25-44c0-9818-e9016dc95ba6"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE (0143-9597-21)", "package_ndc": "0143-9597-21", "marketing_start_date": "20181123"}], "brand_name": "Abiraterone", "product_id": "0143-9597_35e5846f-9299-4190-94bb-6b0bb0d92485", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 17A1 Inhibitor [EPC]", "Cytochrome P450 17A1 Inhibitors [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]"], "product_ndc": "0143-9597", "generic_name": "Abiraterone acetate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Abiraterone", "active_ingredients": [{"name": "ABIRATERONE ACETATE", "strength": "250 mg/1"}], "application_number": "ANDA208339", "marketing_category": "ANDA", "marketing_start_date": "20181123", "listing_expiration_date": "20261231"}