letrozole

Generic: letrozole

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name letrozole
Generic Name letrozole
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

letrozole 2.5 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-476
Product ID 50268-476_48d4cf4a-83a7-4e5f-e063-6394a90a4ece
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200161
Listing Expiration 2027-12-31
Marketing Start 2019-10-02

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 50268476
Hyphenated Format 50268-476

Supplemental Identifiers

RxCUI
200064
UNII
7LKK855W8I
NUI
N0000175563 N0000175080

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
  • 50 BLISTER PACK in 1 BOX (50268-476-15) / 1 TABLET in 1 BLISTER PACK (50268-476-11)
source: ndc

Packages (1)

50268-476-15 50 BLISTER PACK in 1 BOX (50268-476-15) / 1 TABLET in 1 BLISTER PACK (50268-476-11)

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": "48d4cf4a-83a7-4e5f-e063-6394a90a4ece", "openfda": {"nui": ["N0000175563", "N0000175080"], "unii": ["7LKK855W8I"], "rxcui": ["200064"], "spl_set_id": ["93f317f1-96d1-498e-e053-2995a90ac60d"], "pharm_class_epc": ["Aromatase Inhibitor [EPC]"], "pharm_class_moa": ["Aromatase Inhibitors [MoA]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-476-15)  / 1 TABLET in 1 BLISTER PACK (50268-476-11)", "package_ndc": "50268-476-15", "marketing_start_date": "20191002"}], "brand_name": "LETROZOLE", "product_id": "50268-476_48d4cf4a-83a7-4e5f-e063-6394a90a4ece", "dosage_form": "TABLET", "pharm_class": ["Aromatase Inhibitor [EPC]", "Aromatase Inhibitors [MoA]"], "product_ndc": "50268-476", "generic_name": "LETROZOLE", "labeler_name": "AvPAK", "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": "20191002", "listing_expiration_date": "20271231"}