letrozole

Generic: letrozole

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

Drug Facts

Product Profile

Brand Name letrozole
Generic Name letrozole
Labeler accord healthcare, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

letrozole 2.5 mg/1

Manufacturer
Accord Healthcare, Inc.

Identifiers & Regulatory

Product NDC 16729-034
Product ID 16729-034_4a681bf4-9779-a1b2-e063-6294a90a83db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090934
Listing Expiration 2027-12-31
Marketing Start 2011-06-02

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 16729034
Hyphenated Format 16729-034

Supplemental Identifiers

RxCUI
200064
UNII
7LKK855W8I
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 letrozole (source: ndc)
Generic Name letrozole (source: ndc)
Application Number ANDA090934 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (16729-034-10)
  • 90 TABLET, FILM COATED in 1 BOTTLE (16729-034-15)
source: ndc

Packages (2)

16729-034-10 30 TABLET, FILM COATED in 1 BOTTLE (16729-034-10) 16729-034-15 90 TABLET, FILM COATED in 1 BOTTLE (16729-034-15)

Ingredients (1)

letrozole (2.5 mg/1)

Linked Drug Pages (1)

Letrozole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4a681bf4-9779-a1b2-e063-6294a90a83db", "openfda": {"nui": ["N0000175563", "N0000175080"], "unii": ["7LKK855W8I"], "rxcui": ["200064"], "spl_set_id": ["c391fe11-fd47-4a35-af6d-c823ab7b8838"], "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, FILM COATED in 1 BOTTLE (16729-034-10)", "package_ndc": "16729-034-10", "marketing_start_date": "20110602"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (16729-034-15)", "package_ndc": "16729-034-15", "marketing_start_date": "20141231"}], "brand_name": "Letrozole", "product_id": "16729-034_4a681bf4-9779-a1b2-e063-6294a90a83db", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aromatase Inhibitor [EPC]", "Aromatase Inhibitors [MoA]"], "product_ndc": "16729-034", "generic_name": "letrozole", "labeler_name": "Accord Healthcare, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Letrozole", "active_ingredients": [{"name": "LETROZOLE", "strength": "2.5 mg/1"}], "application_number": "ANDA090934", "marketing_category": "ANDA", "marketing_start_date": "20110602", "listing_expiration_date": "20271231"}