abiraterone acetate

Generic: abiraterone acetate

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name abiraterone acetate
Generic Name abiraterone acetate
Labeler northstar rx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

abiraterone acetate 500 mg/1

Manufacturer
NORTHSTAR RX LLC

Identifiers & Regulatory

Product NDC 72603-111
Product ID 72603-111_d344c9ba-435e-4ea9-83b2-4685f3dc3495
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209227
Listing Expiration 2026-12-31
Marketing Start 2022-05-19

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 72603111
Hyphenated Format 72603-111

Supplemental Identifiers

RxCUI
1100075 1918042
UPC
0372603111019 0372603110012
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 ANDA209227 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (72603-111-01)
source: ndc

Packages (1)

72603-111-01 60 TABLET in 1 BOTTLE (72603-111-01)

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": "d344c9ba-435e-4ea9-83b2-4685f3dc3495", "openfda": {"upc": ["0372603111019", "0372603110012"], "unii": ["EM5OCB9YJ6"], "rxcui": ["1100075", "1918042"], "spl_set_id": ["42d5baa8-aca7-49d8-9c24-9d87b707ec20"], "manufacturer_name": ["NORTHSTAR RX LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (72603-111-01)", "package_ndc": "72603-111-01", "marketing_start_date": "20220519"}], "brand_name": "abiraterone acetate", "product_id": "72603-111_d344c9ba-435e-4ea9-83b2-4685f3dc3495", "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": "72603-111", "generic_name": "abiraterone acetate", "labeler_name": "NORTHSTAR RX LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "abiraterone acetate", "active_ingredients": [{"name": "ABIRATERONE ACETATE", "strength": "500 mg/1"}], "application_number": "ANDA209227", "marketing_category": "ANDA", "marketing_start_date": "20220519", "listing_expiration_date": "20261231"}