femara

Generic: letrozole

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name femara
Generic Name letrozole
Labeler novartis pharmaceuticals corporation
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

letrozole 2.5 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0249
Product ID 0078-0249_f052c25a-d848-4b2d-8ff3-73bee0c89ad7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020726
Listing Expiration 2026-12-31
Marketing Start 1997-07-31

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 00780249
Hyphenated Format 0078-0249

Supplemental Identifiers

RxCUI
153124 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 femara (source: ndc)
Generic Name letrozole (source: ndc)
Application Number NDA020726 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0249-15)
source: ndc

Packages (1)

0078-0249-15 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0249-15)

Ingredients (1)

letrozole (2.5 mg/1)

Linked Drug Pages (1)

Femara ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f052c25a-d848-4b2d-8ff3-73bee0c89ad7", "openfda": {"nui": ["N0000175563", "N0000175080"], "unii": ["7LKK855W8I"], "rxcui": ["153124", "200064"], "spl_set_id": ["82b77d74-085f-45ac-a7dd-1f5c038bf406"], "pharm_class_epc": ["Aromatase Inhibitor [EPC]"], "pharm_class_moa": ["Aromatase Inhibitors [MoA]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0249-15)", "package_ndc": "0078-0249-15", "marketing_start_date": "19970731"}], "brand_name": "Femara", "product_id": "0078-0249_f052c25a-d848-4b2d-8ff3-73bee0c89ad7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aromatase Inhibitor [EPC]", "Aromatase Inhibitors [MoA]"], "product_ndc": "0078-0249", "generic_name": "letrozole", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Femara", "active_ingredients": [{"name": "LETROZOLE", "strength": "2.5 mg/1"}], "application_number": "NDA020726", "marketing_category": "NDA", "marketing_start_date": "19970731", "listing_expiration_date": "20261231"}