letrozole

Generic: letrozole tablets

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

Drug Facts

Product Profile

Brand Name letrozole
Generic Name letrozole tablets
Labeler yiling pharmaceutical, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

letrozole 2.5 mg/1

Manufacturer
Yiling Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 69117-0004
Product ID 69117-0004_4721d1b1-3a04-27fb-e063-6394a90a7c1a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205869
Listing Expiration 2026-12-31
Marketing Start 2019-09-05

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 691170004
Hyphenated Format 69117-0004

Supplemental Identifiers

RxCUI
200064
UPC
0369117000410
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 (69117-0004-1)
source: ndc

Packages (1)

69117-0004-1 30 TABLET, FILM COATED in 1 BOTTLE (69117-0004-1)

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": "4721d1b1-3a04-27fb-e063-6394a90a7c1a", "openfda": {"nui": ["N0000175563", "N0000175080"], "upc": ["0369117000410"], "unii": ["7LKK855W8I"], "rxcui": ["200064"], "spl_set_id": ["7b00e08c-9a1c-09e0-e053-2a91aa0a7638"], "pharm_class_epc": ["Aromatase Inhibitor [EPC]"], "pharm_class_moa": ["Aromatase Inhibitors [MoA]"], "manufacturer_name": ["Yiling Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "30 TABLET, FILM COATED in 1 BOTTLE (69117-0004-1)", "package_ndc": "69117-0004-1", "marketing_start_date": "20190905"}], "brand_name": "Letrozole", "product_id": "69117-0004_4721d1b1-3a04-27fb-e063-6394a90a7c1a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aromatase Inhibitor [EPC]", "Aromatase Inhibitors [MoA]"], "product_ndc": "69117-0004", "generic_name": "Letrozole Tablets", "labeler_name": "Yiling Pharmaceutical, Inc.", "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": "20190905", "listing_expiration_date": "20261231"}