anastrozole

Generic: anastrozole

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name anastrozole
Generic Name anastrozole
Labeler asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

anastrozole 1 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-004
Product ID 76420-004_4ad5b64f-c4f3-4aa0-e063-6394a90a8a21
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090568
Listing Expiration 2027-12-31
Marketing Start 2010-06-22

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 76420004
Hyphenated Format 76420-004

Supplemental Identifiers

RxCUI
199224
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 ANDA090568 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 120 TABLET in 1 BOTTLE, PLASTIC (76420-004-12)
  • 150 TABLET in 1 BOTTLE, PLASTIC (76420-004-15)
  • 20 TABLET in 1 BOTTLE, PLASTIC (76420-004-20)
  • 30 TABLET in 1 BOTTLE, PLASTIC (76420-004-30)
source: ndc

Packages (4)

76420-004-12 120 TABLET in 1 BOTTLE, PLASTIC (76420-004-12) 76420-004-15 150 TABLET in 1 BOTTLE, PLASTIC (76420-004-15) 76420-004-20 20 TABLET in 1 BOTTLE, PLASTIC (76420-004-20) 76420-004-30 30 TABLET in 1 BOTTLE, PLASTIC (76420-004-30)

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": "4ad5b64f-c4f3-4aa0-e063-6394a90a8a21", "openfda": {"nui": ["N0000175563", "N0000175080"], "unii": ["2Z07MYW1AZ"], "rxcui": ["199224"], "spl_set_id": ["b964f555-25d2-47ad-8942-f195f062445c"], "pharm_class_epc": ["Aromatase Inhibitor [EPC]"], "pharm_class_moa": ["Aromatase Inhibitors [MoA]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE, PLASTIC (76420-004-12)", "package_ndc": "76420-004-12", "marketing_start_date": "20191224"}, {"sample": false, "description": "150 TABLET in 1 BOTTLE, PLASTIC (76420-004-15)", "package_ndc": "76420-004-15", "marketing_start_date": "20191224"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (76420-004-20)", "package_ndc": "76420-004-20", "marketing_start_date": "20191224"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (76420-004-30)", "package_ndc": "76420-004-30", "marketing_start_date": "20191224"}], "brand_name": "Anastrozole", "product_id": "76420-004_4ad5b64f-c4f3-4aa0-e063-6394a90a8a21", "dosage_form": "TABLET", "pharm_class": ["Aromatase Inhibitor [EPC]", "Aromatase Inhibitors [MoA]"], "product_ndc": "76420-004", "generic_name": "Anastrozole", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Anastrozole", "active_ingredients": [{"name": "ANASTROZOLE", "strength": "1 mg/1"}], "application_number": "ANDA090568", "marketing_category": "ANDA", "marketing_start_date": "20100622", "listing_expiration_date": "20271231"}