abirtega

Generic: abiraterone acetate

Labeler: civicascript, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name abirtega
Generic Name abiraterone acetate
Labeler civicascript, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

abiraterone acetate 250 mg/1

Manufacturer
CivicaScript, LLC

Identifiers & Regulatory

Product NDC 82249-011
Product ID 82249-011_692d596d-5465-4611-82f7-5d50c37270a2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208339
Listing Expiration 2026-12-31
Marketing Start 2018-11-23

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 82249011
Hyphenated Format 82249-011

Supplemental Identifiers

RxCUI
1100075 2702601
UPC
0382249011123
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 abirtega (source: ndc)
Generic Name abiraterone acetate (source: ndc)
Application Number ANDA208339 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 120 TABLET in 1 BOTTLE, PLASTIC (82249-011-12)
source: ndc

Packages (1)

82249-011-12 120 TABLET in 1 BOTTLE, PLASTIC (82249-011-12)

Ingredients (1)

abiraterone acetate (250 mg/1)

Linked Drug Pages (1)

Abirtega ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL", "ORAL"], "spl_id": "692d596d-5465-4611-82f7-5d50c37270a2", "openfda": {"upc": ["0382249011123"], "unii": ["EM5OCB9YJ6"], "rxcui": ["1100075", "2702601"], "spl_set_id": ["2f932015-28b2-4f44-ac04-772e982e13e9"], "manufacturer_name": ["CivicaScript, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE, PLASTIC (82249-011-12)", "package_ndc": "82249-011-12", "marketing_start_date": "20250117"}], "brand_name": "Abirtega", "product_id": "82249-011_692d596d-5465-4611-82f7-5d50c37270a2", "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": "82249-011", "generic_name": "Abiraterone acetate", "labeler_name": "CivicaScript, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Abirtega", "active_ingredients": [{"name": "ABIRATERONE ACETATE", "strength": "250 mg/1"}], "application_number": "ANDA208339", "marketing_category": "ANDA", "marketing_start_date": "20181123", "listing_expiration_date": "20261231"}