Letrozole

Product NDC
71335-2396
11-digit product format
713352396
Labeler code
71335
Product ID
71335-2396_77bb27a8-b20e-44eb-b96c-ff1a364a24d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Letrozole Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205869
Marketing category
ANDA
Marketing start
2023-06-01
Substance
LETROZOLE
Active strength
2.5 mg/1
Pharmacologic classes
Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
7LKK855W8ILETROZOLE112809-51-5LETROZOLE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2396-17133523960130 TABLET, FILM COATED in 1 BOTTLE (71335-2396-1) 2024-04-19NoNoHistorical
71335-2396-27133523960210 TABLET, FILM COATED in 1 BOTTLE (71335-2396-2) 2025-01-03NoNoHistorical
71335-2396-37133523960390 TABLET, FILM COATED in 1 BOTTLE (71335-2396-3) 2025-01-31NoNoHistorical
71335-2396-47133523960440 TABLET, FILM COATED in 1 BOTTLE (71335-2396-4) 2025-01-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Letrozole TabletsBryant Ranch Prepack2025-01-31HUMAN PRESCRIPTION DRUG LABEL2