letrozole

Generic: letrozole

Labeler: natco pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name letrozole
Generic Name letrozole
Labeler natco pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

letrozole 2.5 mg/1

Manufacturer
Natco Pharma Limited

Identifiers & Regulatory

Product NDC 63850-0025
Product ID 63850-0025_7917d6e0-df93-4c10-97c9-3d90b00b7bd4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200161
Listing Expiration 2026-12-31
Marketing Start 2011-06-03

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 638500025
Hyphenated Format 63850-0025

Supplemental Identifiers

RxCUI
200064
UPC
0363850002540
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 ANDA200161 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (63850-0025-1)
  • 1000 TABLET in 1 BOTTLE (63850-0025-4)
source: ndc

Packages (2)

63850-0025-1 30 TABLET in 1 BOTTLE (63850-0025-1) 63850-0025-4 1000 TABLET in 1 BOTTLE (63850-0025-4)

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": "7917d6e0-df93-4c10-97c9-3d90b00b7bd4", "openfda": {"nui": ["N0000175563", "N0000175080"], "upc": ["0363850002540"], "unii": ["7LKK855W8I"], "rxcui": ["200064"], "spl_set_id": ["35c73219-c39e-4e10-b944-76009b061e79"], "pharm_class_epc": ["Aromatase Inhibitor [EPC]"], "pharm_class_moa": ["Aromatase Inhibitors [MoA]"], "manufacturer_name": ["Natco Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (63850-0025-1)", "package_ndc": "63850-0025-1", "marketing_start_date": "20110603"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (63850-0025-4)", "package_ndc": "63850-0025-4", "marketing_start_date": "20110603"}], "brand_name": "Letrozole", "product_id": "63850-0025_7917d6e0-df93-4c10-97c9-3d90b00b7bd4", "dosage_form": "TABLET", "pharm_class": ["Aromatase Inhibitor [EPC]", "Aromatase Inhibitors [MoA]"], "product_ndc": "63850-0025", "generic_name": "Letrozole", "labeler_name": "Natco Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Letrozole", "active_ingredients": [{"name": "LETROZOLE", "strength": "2.5 mg/1"}], "application_number": "ANDA200161", "marketing_category": "ANDA", "marketing_start_date": "20110603", "listing_expiration_date": "20261231"}