letrozole

Generic: letrozole

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name letrozole
Generic Name letrozole
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

letrozole 2.5 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-7620
Product ID 0093-7620_c91fb703-e253-490e-bb1d-48d054d81c6e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090289
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 00937620
Hyphenated Format 0093-7620

Supplemental Identifiers

RxCUI
200064
UPC
0300937620563
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 ANDA090289 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0093-7620-56)
source: ndc

Packages (1)

0093-7620-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-7620-56)

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": "c91fb703-e253-490e-bb1d-48d054d81c6e", "openfda": {"nui": ["N0000175563", "N0000175080"], "upc": ["0300937620563"], "unii": ["7LKK855W8I"], "rxcui": ["200064"], "spl_set_id": ["8ebda73d-82a3-4b17-8a81-a1f258003d32"], "pharm_class_epc": ["Aromatase Inhibitor [EPC]"], "pharm_class_moa": ["Aromatase Inhibitors [MoA]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0093-7620-56)", "package_ndc": "0093-7620-56", "marketing_start_date": "20110603"}], "brand_name": "Letrozole", "product_id": "0093-7620_c91fb703-e253-490e-bb1d-48d054d81c6e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aromatase Inhibitor [EPC]", "Aromatase Inhibitors [MoA]"], "product_ndc": "0093-7620", "generic_name": "Letrozole", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Letrozole", "active_ingredients": [{"name": "LETROZOLE", "strength": "2.5 mg/1"}], "application_number": "ANDA090289", "marketing_category": "ANDA", "marketing_start_date": "20110603", "listing_expiration_date": "20261231"}