anastrozole

Generic: anastrozole

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

anastrozole 1 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-209
Product ID 68382-209_577b7171-5da0-4291-af07-5e4653ffb3aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078921
Listing Expiration 2026-12-31
Marketing Start 2010-06-27

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 68382209
Hyphenated Format 68382-209

Supplemental Identifiers

RxCUI
199224
UNII
2Z07MYW1AZ
NUI
N0000175563 N0000175080

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 anastrozole (source: ndc)
Generic Name anastrozole (source: ndc)
Application Number ANDA078921 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE (68382-209-06)
  • 1000 TABLET, COATED in 1 BOTTLE (68382-209-10)
source: ndc

Packages (2)

68382-209-06 30 TABLET, COATED in 1 BOTTLE (68382-209-06) 68382-209-10 1000 TABLET, COATED in 1 BOTTLE (68382-209-10)

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": "577b7171-5da0-4291-af07-5e4653ffb3aa", "openfda": {"nui": ["N0000175563", "N0000175080"], "unii": ["2Z07MYW1AZ"], "rxcui": ["199224"], "spl_set_id": ["ca16f8de-d9a5-4c6c-957b-ae28497b67ac"], "pharm_class_epc": ["Aromatase Inhibitor [EPC]"], "pharm_class_moa": ["Aromatase Inhibitors [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (68382-209-06)", "package_ndc": "68382-209-06", "marketing_start_date": "20100627"}, {"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE (68382-209-10)", "package_ndc": "68382-209-10", "marketing_start_date": "20100627"}], "brand_name": "Anastrozole", "product_id": "68382-209_577b7171-5da0-4291-af07-5e4653ffb3aa", "dosage_form": "TABLET, COATED", "pharm_class": ["Aromatase Inhibitor [EPC]", "Aromatase Inhibitors [MoA]"], "product_ndc": "68382-209", "generic_name": "Anastrozole", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Anastrozole", "active_ingredients": [{"name": "ANASTROZOLE", "strength": "1 mg/1"}], "application_number": "ANDA078921", "marketing_category": "ANDA", "marketing_start_date": "20100627", "listing_expiration_date": "20261231"}