letrozole

Generic: letrozole

Labeler: breckenridge pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name letrozole
Generic Name letrozole
Labeler breckenridge pharmaceutical, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

letrozole 2.5 mg/1

Manufacturer
Breckenridge Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 51991-759
Product ID 51991-759_35b275df-f687-4e29-828b-637d5377cc73
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200161
Listing Expiration 2026-12-31
Marketing Start 2011-06-04

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 51991759
Hyphenated Format 51991-759

Supplemental Identifiers

RxCUI
200064
UPC
0351991759904
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
  • 1000 TABLET in 1 BOTTLE (51991-759-10)
  • 30 TABLET in 1 BOTTLE (51991-759-33)
  • 90 TABLET in 1 BOTTLE (51991-759-90)
source: ndc

Packages (3)

51991-759-10 1000 TABLET in 1 BOTTLE (51991-759-10) 51991-759-33 30 TABLET in 1 BOTTLE (51991-759-33) 51991-759-90 90 TABLET in 1 BOTTLE (51991-759-90)

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": "35b275df-f687-4e29-828b-637d5377cc73", "openfda": {"nui": ["N0000175563", "N0000175080"], "upc": ["0351991759904"], "unii": ["7LKK855W8I"], "rxcui": ["200064"], "spl_set_id": ["63e54b62-a30d-4a56-9215-75e7a0b0bf02"], "pharm_class_epc": ["Aromatase Inhibitor [EPC]"], "pharm_class_moa": ["Aromatase Inhibitors [MoA]"], "manufacturer_name": ["Breckenridge Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (51991-759-10)", "package_ndc": "51991-759-10", "marketing_start_date": "20110604"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (51991-759-33)", "package_ndc": "51991-759-33", "marketing_start_date": "20110604"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (51991-759-90)", "package_ndc": "51991-759-90", "marketing_start_date": "20221001"}], "brand_name": "LETROZOLE", "product_id": "51991-759_35b275df-f687-4e29-828b-637d5377cc73", "dosage_form": "TABLET", "pharm_class": ["Aromatase Inhibitor [EPC]", "Aromatase Inhibitors [MoA]"], "product_ndc": "51991-759", "generic_name": "LETROZOLE", "labeler_name": "Breckenridge Pharmaceutical, Inc.", "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": "20110604", "listing_expiration_date": "20261231"}