abiraterone acetate

Generic: abiraterone

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

Drug Facts

Product Profile

Brand Name abiraterone acetate
Generic Name abiraterone
Labeler amneal pharmaceuticals ny llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

abiraterone acetate 250 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 60219-1165
Product ID 60219-1165_7f57b4d0-9c5f-4714-830b-c7736c3d8b2d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208327
Listing Expiration 2026-12-31
Marketing Start 2023-04-28

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 602191165
Hyphenated Format 60219-1165

Supplemental Identifiers

RxCUI
1100075 1918042
UPC
0360219116573 0360219175464
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 (source: ndc)
Application Number ANDA208327 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 120 TABLET in 1 BOTTLE (60219-1165-7)
source: ndc

Packages (1)

60219-1165-7 120 TABLET in 1 BOTTLE (60219-1165-7)

Ingredients (1)

abiraterone acetate (250 mg/1)

Linked Drug Pages (1)

Abiraterone Acetate, ABIRATERONE ACETATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7f57b4d0-9c5f-4714-830b-c7736c3d8b2d", "openfda": {"upc": ["0360219116573", "0360219175464"], "unii": ["EM5OCB9YJ6"], "rxcui": ["1100075", "1918042"], "spl_set_id": ["6fda6b92-59ed-4180-af68-94052a5e82cf"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE (60219-1165-7)", "package_ndc": "60219-1165-7", "marketing_start_date": "20230428"}], "brand_name": "Abiraterone Acetate", "product_id": "60219-1165_7f57b4d0-9c5f-4714-830b-c7736c3d8b2d", "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": "60219-1165", "generic_name": "Abiraterone", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Abiraterone Acetate", "active_ingredients": [{"name": "ABIRATERONE ACETATE", "strength": "250 mg/1"}], "application_number": "ANDA208327", "marketing_category": "ANDA", "marketing_start_date": "20230428", "listing_expiration_date": "20261231"}