abiraterone

Generic: abiraterone acetate

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name abiraterone
Generic Name abiraterone acetate
Labeler bluepoint laboratories
Dosage Form TABLET
Routes
ORAL
Active Ingredients

abiraterone acetate 500 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-673
Product ID 68001-673_3c12fe0b-726d-dcf2-e063-6394a90ad7a3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210686
Listing Expiration 2026-12-31
Marketing Start 2025-09-01

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 68001673
Hyphenated Format 68001-673

Supplemental Identifiers

RxCUI
1100075 1918042
UPC
0368001489072 0368001673068
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 in 1 BOTTLE (68001-673-06)
source: ndc

Packages (1)

68001-673-06 60 TABLET in 1 BOTTLE (68001-673-06)

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": "3c12fe0b-726d-dcf2-e063-6394a90ad7a3", "openfda": {"upc": ["0368001489072", "0368001673068"], "unii": ["EM5OCB9YJ6"], "rxcui": ["1100075", "1918042"], "spl_set_id": ["32f6b83d-c743-4934-9a20-1b5bf9f4eea3"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (68001-673-06)", "package_ndc": "68001-673-06", "marketing_start_date": "20250901"}], "brand_name": "Abiraterone", "product_id": "68001-673_3c12fe0b-726d-dcf2-e063-6394a90ad7a3", "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": "68001-673", "generic_name": "Abiraterone Acetate", "labeler_name": "BluePoint Laboratories", "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": "20250901", "listing_expiration_date": "20261231"}