anastrozole

Generic: anastrozole

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name anastrozole
Generic Name anastrozole
Labeler avkare
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

anastrozole 1 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-085
Product ID 42291-085_485b734b-5e6d-f952-e063-6394a90a3aff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078058
Listing Expiration 2027-12-31
Marketing Start 2020-03-13

Pharmacologic Class

Established (EPC)
aromatase inhibitor [epc]
Mechanism of Action
aromatase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291085
Hyphenated Format 42291-085

Supplemental Identifiers

RxCUI
199224
UPC
0342291085305
UNII
2Z07MYW1AZ
NUI
N0000175563 N0000175080

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 anastrozole (source: ndc)
Generic Name anastrozole (source: ndc)
Application Number ANDA078058 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (42291-085-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (42291-085-90)
source: ndc

Packages (2)

42291-085-30 30 TABLET, FILM COATED in 1 BOTTLE (42291-085-30) 42291-085-90 90 TABLET, FILM COATED in 1 BOTTLE (42291-085-90)

Ingredients (1)

anastrozole (1 mg/1)

Linked Drug Pages (1)

Anastrozole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "485b734b-5e6d-f952-e063-6394a90a3aff", "openfda": {"nui": ["N0000175563", "N0000175080"], "upc": ["0342291085305"], "unii": ["2Z07MYW1AZ"], "rxcui": ["199224"], "spl_set_id": ["a0c2672b-e07b-4f6c-e053-2a95a90a2e5d"], "pharm_class_epc": ["Aromatase Inhibitor [EPC]"], "pharm_class_moa": ["Aromatase Inhibitors [MoA]"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (42291-085-30)", "package_ndc": "42291-085-30", "marketing_start_date": "20200313"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (42291-085-90)", "package_ndc": "42291-085-90", "marketing_start_date": "20200923"}], "brand_name": "Anastrozole", "product_id": "42291-085_485b734b-5e6d-f952-e063-6394a90a3aff", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aromatase Inhibitor [EPC]", "Aromatase Inhibitors [MoA]"], "product_ndc": "42291-085", "generic_name": "Anastrozole", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Anastrozole", "active_ingredients": [{"name": "ANASTROZOLE", "strength": "1 mg/1"}], "application_number": "ANDA078058", "marketing_category": "ANDA", "marketing_start_date": "20200313", "listing_expiration_date": "20271231"}