letrozole

Generic: letrozole

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name letrozole
Generic Name letrozole
Labeler chartwell rx, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

letrozole 2.5 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-491
Product ID 62135-491_456ed484-059b-2ee9-e063-6294a90a3f83
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205869
Listing Expiration 2026-12-31
Marketing Start 2019-05-09

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 62135491
Hyphenated Format 62135-491

Supplemental Identifiers

RxCUI
200064
UPC
0362135491307 0362135491901
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 ANDA205869 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (62135-491-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (62135-491-90)
source: ndc

Packages (2)

62135-491-30 30 TABLET, FILM COATED in 1 BOTTLE (62135-491-30) 62135-491-90 90 TABLET, FILM COATED in 1 BOTTLE (62135-491-90)

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": "456ed484-059b-2ee9-e063-6294a90a3f83", "openfda": {"nui": ["N0000175563", "N0000175080"], "upc": ["0362135491307", "0362135491901"], "unii": ["7LKK855W8I"], "rxcui": ["200064"], "spl_set_id": ["fa2d40a5-3504-44ef-8f5c-aa4c06308074"], "pharm_class_epc": ["Aromatase Inhibitor [EPC]"], "pharm_class_moa": ["Aromatase Inhibitors [MoA]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (62135-491-30)", "package_ndc": "62135-491-30", "marketing_start_date": "20220117"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (62135-491-90)", "package_ndc": "62135-491-90", "marketing_start_date": "20220117"}], "brand_name": "LETROZOLE", "product_id": "62135-491_456ed484-059b-2ee9-e063-6294a90a3f83", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aromatase Inhibitor [EPC]", "Aromatase Inhibitors [MoA]"], "product_ndc": "62135-491", "generic_name": "Letrozole", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LETROZOLE", "active_ingredients": [{"name": "LETROZOLE", "strength": "2.5 mg/1"}], "application_number": "ANDA205869", "marketing_category": "ANDA", "marketing_start_date": "20190509", "listing_expiration_date": "20261231"}