abiraterone acetate

Generic: abiraterone acetate

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

Drug Facts

Product Profile

Brand Name abiraterone acetate
Generic Name abiraterone acetate
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

abiraterone acetate 500 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-6921
Product ID 0378-6921_99ab6459-db02-4abd-9689-6c4c43021119
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208446
Listing Expiration 2026-12-31
Marketing Start 2020-12-14

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 03786921
Hyphenated Format 0378-6921

Supplemental Identifiers

RxCUI
1100075 1918042
UPC
0303786921911 0303786920785
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 ANDA208446 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6921-91)
source: ndc

Packages (1)

0378-6921-91 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6921-91)

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": "99ab6459-db02-4abd-9689-6c4c43021119", "openfda": {"upc": ["0303786921911", "0303786920785"], "unii": ["EM5OCB9YJ6"], "rxcui": ["1100075", "1918042"], "spl_set_id": ["fe02db79-fa04-441f-b514-70bd74af6624"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6921-91)", "package_ndc": "0378-6921-91", "marketing_start_date": "20201214"}], "brand_name": "Abiraterone Acetate", "product_id": "0378-6921_99ab6459-db02-4abd-9689-6c4c43021119", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 17A1 Inhibitor [EPC]", "Cytochrome P450 17A1 Inhibitors [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]"], "product_ndc": "0378-6921", "generic_name": "abiraterone acetate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Abiraterone Acetate", "active_ingredients": [{"name": "ABIRATERONE ACETATE", "strength": "500 mg/1"}], "application_number": "ANDA208446", "marketing_category": "ANDA", "marketing_start_date": "20201214", "listing_expiration_date": "20261231"}