abiraterone acetate

Generic: abiraterone acetate

Labeler: novugen pharma (usa) llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name abiraterone acetate
Generic Name abiraterone acetate
Labeler novugen pharma (usa) llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

abiraterone acetate 500 mg/1

Manufacturer
Novugen Pharma (USA) LLC

Identifiers & Regulatory

Product NDC 82293-002
Product ID 82293-002_47d0b34a-b255-d3a9-e063-6294a90aadb6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215947
Listing Expiration 2027-12-31
Marketing Start 2022-01-05

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 82293002
Hyphenated Format 82293-002

Supplemental Identifiers

RxCUI
1100075 1918042
UPC
0382293002108 0382293001101
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 ANDA215947 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82293-002-10)
source: ndc

Packages (1)

82293-002-10 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82293-002-10)

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": "47d0b34a-b255-d3a9-e063-6294a90aadb6", "openfda": {"upc": ["0382293002108", "0382293001101"], "unii": ["EM5OCB9YJ6"], "rxcui": ["1100075", "1918042"], "spl_set_id": ["f308b463-27e4-422a-95a2-ecbbf95eee20"], "manufacturer_name": ["Novugen Pharma (USA) LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82293-002-10)", "package_ndc": "82293-002-10", "marketing_start_date": "20220105"}], "brand_name": "Abiraterone Acetate", "product_id": "82293-002_47d0b34a-b255-d3a9-e063-6294a90aadb6", "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": "82293-002", "generic_name": "abiraterone acetate", "labeler_name": "Novugen Pharma (USA) LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Abiraterone Acetate", "active_ingredients": [{"name": "ABIRATERONE ACETATE", "strength": "500 mg/1"}], "application_number": "ANDA215947", "marketing_category": "ANDA", "marketing_start_date": "20220105", "listing_expiration_date": "20271231"}