NDC 68382-363

letrozole

Letrozole

letrozole is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Letrozole.

Product ID68382-363_a7dfded8-37bd-4d82-afff-2065e6ba24a8
NDC68382-363
Product TypeHuman Prescription Drug
Proprietary Nameletrozole
Generic NameLetrozole
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-06-03
Marketing CategoryANDA / ANDA
Application NumberANDA090405
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameLETROZOLE
Active Ingredient Strength3 mg/1
Pharm ClassesAromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68382-363-30

10 BLISTER PACK in 1 CARTON (68382-363-30) > 10 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2011-06-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-363-06 [68382036306]

letrozole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090405
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-06-03
Inactivation Date2019-10-29

NDC 68382-363-30 [68382036330]

letrozole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090405
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-06-03
Inactivation Date2019-10-29

NDC 68382-363-10 [68382036310]

letrozole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090405
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-06-03
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
LETROZOLE2.5 mg/1

Pharmacological Class

  • Aromatase Inhibitor [EPC]
  • Aromatase Inhibitors [MoA]

NDC Crossover Matching brand name "letrozole" or generic name "Letrozole"

NDCBrand NameGeneric Name
0093-7620LetrozoleLetrozole
16729-034Letrozoleletrozole
17856-0032Letrozoleletrozole
24535-0801LETROZOLELETROZOLE
24724-030LETROZOLELETROZOLE
42254-243LetrozoleLetrozole
42291-374LetrozoleLetrozole
50090-3474Letrozoleletrozole
50268-476LETROZOLELETROZOLE
51991-759LETROZOLELETROZOLE
55111-646LetrozoleLetrozole
57884-2021LETROZOLELETROZOLE
59651-180LetrozoleLetrozole
60505-3255LetrozoleLetrozole
62135-491LETROZOLELetrozole
62756-511LETROZOLELETROZOLE
63629-7819Letrozoleletrozole
63850-0025LetrozoleLetrozole
65841-744letrozoleletrozole
68071-5264Letrozoleletrozole
68084-803LetrozoleLetrozole
68382-363letrozoleletrozole
69117-0004LetrozoleLetrozole Tablets
70518-1869LetrozoleLetrozole
70518-2020LetrozoleLetrozole
71335-1526LETROZOLELETROZOLE
0078-0249Femaraletrozole

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