abiraterone acetate

Generic: abiraterone acetate

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

Drug Facts

Product Profile

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

abiraterone acetate 250 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-135
Product ID 68462-135_ccb0d191-e233-4e8c-9485-044cbbdba4aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209227
Listing Expiration 2027-12-31
Marketing Start 2019-10-16

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 68462135
Hyphenated Format 68462-135

Supplemental Identifiers

RxCUI
1100075 1918042
UPC
0368462882603
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
  • 250 mg/1
source: ndc
Packaging
  • 120 TABLET in 1 BOTTLE (68462-135-08)
source: ndc

Packages (1)

68462-135-08 120 TABLET in 1 BOTTLE (68462-135-08)

Ingredients (1)

abiraterone acetate (250 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": "ccb0d191-e233-4e8c-9485-044cbbdba4aa", "openfda": {"upc": ["0368462882603"], "unii": ["EM5OCB9YJ6"], "rxcui": ["1100075", "1918042"], "spl_set_id": ["ba32c453-a231-452a-a6d9-b3e57afb2e75"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE (68462-135-08)", "package_ndc": "68462-135-08", "marketing_start_date": "20191016"}], "brand_name": "abiraterone acetate", "product_id": "68462-135_ccb0d191-e233-4e8c-9485-044cbbdba4aa", "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": "68462-135", "generic_name": "abiraterone acetate", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "abiraterone acetate", "active_ingredients": [{"name": "ABIRATERONE ACETATE", "strength": "250 mg/1"}], "application_number": "ANDA209227", "marketing_category": "ANDA", "marketing_start_date": "20191016", "listing_expiration_date": "20271231"}