letrozole

Generic: letrozole tablets

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name letrozole
Generic Name letrozole tablets
Labeler upsher-smith laboratories, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

letrozole 2.5 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 24979-726
Product ID 24979-726_e1ad4249-b98b-4370-9ff8-f1d95b7b400a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205869
Listing Expiration 2026-12-31
Marketing Start 2025-01-10

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 24979726
Hyphenated Format 24979-726

Supplemental Identifiers

RxCUI
200064
UPC
0324979726069 0324979726076
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 tablets (source: ndc)
Application Number ANDA205869 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (24979-726-06)
  • 90 TABLET, FILM COATED in 1 BOTTLE (24979-726-07)
source: ndc

Packages (2)

24979-726-06 30 TABLET, FILM COATED in 1 BOTTLE (24979-726-06) 24979-726-07 90 TABLET, FILM COATED in 1 BOTTLE (24979-726-07)

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": "e1ad4249-b98b-4370-9ff8-f1d95b7b400a", "openfda": {"nui": ["N0000175563", "N0000175080"], "upc": ["0324979726069", "0324979726076"], "unii": ["7LKK855W8I"], "rxcui": ["200064"], "spl_set_id": ["2d1f18f0-2c77-407c-b702-2d1b07f92510"], "pharm_class_epc": ["Aromatase Inhibitor [EPC]"], "pharm_class_moa": ["Aromatase Inhibitors [MoA]"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (24979-726-06)", "package_ndc": "24979-726-06", "marketing_start_date": "20250110"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (24979-726-07)", "package_ndc": "24979-726-07", "marketing_start_date": "20250110"}], "brand_name": "Letrozole", "product_id": "24979-726_e1ad4249-b98b-4370-9ff8-f1d95b7b400a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aromatase Inhibitor [EPC]", "Aromatase Inhibitors [MoA]"], "product_ndc": "24979-726", "generic_name": "Letrozole Tablets", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Letrozole", "active_ingredients": [{"name": "LETROZOLE", "strength": "2.5 mg/1"}], "application_number": "ANDA205869", "marketing_category": "ANDA", "marketing_start_date": "20250110", "listing_expiration_date": "20261231"}