letrozole

Generic: letrozole

Labeler: dr. reddy's laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name letrozole
Generic Name letrozole
Labeler dr. reddy's laboratories limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

letrozole 2.5 mg/1

Manufacturer
Dr. Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-646
Product ID 55111-646_ec1b249b-2d77-55d9-0520-23884a961cf0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091191
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 55111646
Hyphenated Format 55111-646

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 ANDA091191 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (55111-646-30)
  • 10 BLISTER PACK in 1 CARTON (55111-646-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-646-79)
source: ndc

Packages (2)

55111-646-30 30 TABLET, FILM COATED in 1 BOTTLE (55111-646-30) 55111-646-78 10 BLISTER PACK in 1 CARTON (55111-646-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-646-79)

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": "ec1b249b-2d77-55d9-0520-23884a961cf0", "openfda": {"nui": ["N0000175563", "N0000175080"], "unii": ["7LKK855W8I"], "rxcui": ["200064"], "spl_set_id": ["6cfd29d7-f519-7b8c-4814-07b39f367f0d"], "pharm_class_epc": ["Aromatase Inhibitor [EPC]"], "pharm_class_moa": ["Aromatase Inhibitors [MoA]"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (55111-646-30)", "package_ndc": "55111-646-30", "marketing_start_date": "20110603"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (55111-646-78)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-646-79)", "package_ndc": "55111-646-78", "marketing_start_date": "20110603"}], "brand_name": "Letrozole", "product_id": "55111-646_ec1b249b-2d77-55d9-0520-23884a961cf0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aromatase Inhibitor [EPC]", "Aromatase Inhibitors [MoA]"], "product_ndc": "55111-646", "generic_name": "Letrozole", "labeler_name": "Dr. Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Letrozole", "active_ingredients": [{"name": "LETROZOLE", "strength": "2.5 mg/1"}], "application_number": "ANDA091191", "marketing_category": "ANDA", "marketing_start_date": "20110603", "listing_expiration_date": "20261231"}