anastrozole

Generic: anastrozole

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name anastrozole
Generic Name anastrozole
Labeler accord healthcare inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

anastrozole 1 mg/1

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-035
Product ID 16729-035_4a900d2c-12d3-6bfa-e063-6294a90af009
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 16729035
Hyphenated Format 16729-035

Supplemental Identifiers

RxCUI
199224
UPC
0316729035101
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 ANDA090568 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (16729-035-10)
  • 90 TABLET in 1 BOTTLE, PLASTIC (16729-035-15)
  • 500 TABLET in 1 BOTTLE, PLASTIC (16729-035-16)
source: ndc

Packages (3)

Ingredients (1)

anastrozole (1 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "4a900d2c-12d3-6bfa-e063-6294a90af009", "openfda": {"nui": ["N0000175563", "N0000175080"], "upc": ["0316729035101"], "unii": ["2Z07MYW1AZ"], "rxcui": ["199224"], "spl_set_id": ["03586c40-eb32-45c5-beb7-6762a6b78790"], "pharm_class_epc": ["Aromatase Inhibitor [EPC]"], "pharm_class_moa": ["Aromatase Inhibitors [MoA]"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (16729-035-10)", "package_ndc": "16729-035-10", "marketing_start_date": "20100622"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (16729-035-15)", "package_ndc": "16729-035-15", "marketing_start_date": "20110224"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (16729-035-16)", "package_ndc": "16729-035-16", "marketing_start_date": "20110321"}], "brand_name": "Anastrozole", "product_id": "16729-035_4a900d2c-12d3-6bfa-e063-6294a90af009", "dosage_form": "TABLET", "pharm_class": ["Aromatase Inhibitor [EPC]", "Aromatase Inhibitors [MoA]"], "product_ndc": "16729-035", "generic_name": "Anastrozole", "labeler_name": "Accord Healthcare 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"}