abiraterone acetate

Generic: abiraterone acetate

Labeler: dr. reddys laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name abiraterone acetate
Generic Name abiraterone acetate
Labeler dr. reddys laboratories inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

abiraterone acetate 500 mg/1

Manufacturer
Dr. Reddys Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-468
Product ID 43598-468_5e7f1aec-5727-4e71-1a05-55e8eef89e0a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208416
Listing Expiration 2026-12-31
Marketing Start 2023-09-11

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 43598468
Hyphenated Format 43598-468

Supplemental Identifiers

RxCUI
1100075 1918042
UPC
0343598358048
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 ANDA208416 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 6 BLISTER PACK in 1 CARTON (43598-468-38) / 10 TABLET in 1 BLISTER PACK (43598-468-79)
  • 60 TABLET in 1 BOTTLE (43598-468-60)
source: ndc

Packages (2)

43598-468-38 6 BLISTER PACK in 1 CARTON (43598-468-38) / 10 TABLET in 1 BLISTER PACK (43598-468-79) 43598-468-60 60 TABLET in 1 BOTTLE (43598-468-60)

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": "5e7f1aec-5727-4e71-1a05-55e8eef89e0a", "openfda": {"upc": ["0343598358048"], "unii": ["EM5OCB9YJ6"], "rxcui": ["1100075", "1918042"], "spl_set_id": ["7eda0d98-c2ba-c117-b757-1f566292e789"], "manufacturer_name": ["Dr. Reddys Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BLISTER PACK in 1 CARTON (43598-468-38)  / 10 TABLET in 1 BLISTER PACK (43598-468-79)", "package_ndc": "43598-468-38", "marketing_start_date": "20230911"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (43598-468-60)", "package_ndc": "43598-468-60", "marketing_start_date": "20230911"}], "brand_name": "Abiraterone Acetate", "product_id": "43598-468_5e7f1aec-5727-4e71-1a05-55e8eef89e0a", "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": "43598-468", "generic_name": "Abiraterone Acetate", "labeler_name": "Dr. Reddys Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Abiraterone Acetate", "active_ingredients": [{"name": "ABIRATERONE ACETATE", "strength": "500 mg/1"}], "application_number": "ANDA208416", "marketing_category": "ANDA", "marketing_start_date": "20230911", "listing_expiration_date": "20261231"}