letrozole

Generic: letrozole

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

Drug Facts

Product Profile

Brand Name letrozole
Generic Name letrozole
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

letrozole 2.5 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-180
Product ID 59651-180_2cd5dbfd-2432-4cea-bee2-6b710b5d28a2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211717
Listing Expiration 2026-12-31
Marketing Start 2019-01-11

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 59651180
Hyphenated Format 59651-180

Supplemental Identifiers

RxCUI
200064
UPC
0359651180907 0359651180303
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 ANDA211717 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (59651-180-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (59651-180-90)
source: ndc

Packages (2)

59651-180-30 30 TABLET, FILM COATED in 1 BOTTLE (59651-180-30) 59651-180-90 90 TABLET, FILM COATED in 1 BOTTLE (59651-180-90)

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": "2cd5dbfd-2432-4cea-bee2-6b710b5d28a2", "openfda": {"nui": ["N0000175563", "N0000175080"], "upc": ["0359651180907", "0359651180303"], "unii": ["7LKK855W8I"], "rxcui": ["200064"], "spl_set_id": ["ff7325d2-3383-4ff9-a187-9350e3538640"], "pharm_class_epc": ["Aromatase Inhibitor [EPC]"], "pharm_class_moa": ["Aromatase Inhibitors [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (59651-180-30)", "package_ndc": "59651-180-30", "marketing_start_date": "20190111"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (59651-180-90)", "package_ndc": "59651-180-90", "marketing_start_date": "20190111"}], "brand_name": "Letrozole", "product_id": "59651-180_2cd5dbfd-2432-4cea-bee2-6b710b5d28a2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aromatase Inhibitor [EPC]", "Aromatase Inhibitors [MoA]"], "product_ndc": "59651-180", "generic_name": "Letrozole", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Letrozole", "active_ingredients": [{"name": "LETROZOLE", "strength": "2.5 mg/1"}], "application_number": "ANDA211717", "marketing_category": "ANDA", "marketing_start_date": "20190111", "listing_expiration_date": "20261231"}