NDC 70518-2020

Letrozole

Letrozole

Letrozole is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Letrozole.

Product ID70518-2020_869c5b2f-393a-1eec-e053-2a91aa0a618a
NDC70518-2020
Product TypeHuman Prescription Drug
Proprietary NameLetrozole
Generic NameLetrozole
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-04-15
Marketing CategoryANDA / ANDA
Application NumberANDA090289
Labeler NameREMEDYREPACK INC.
Substance NameLETROZOLE
Active Ingredient Strength3 mg/1
Pharm ClassesAromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-2020-0

30 POUCH in 1 BOX (70518-2020-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-2020-1)
Marketing Start Date2019-04-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-2020-1 [70518202001]

Letrozole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090289
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-15

NDC 70518-2020-0 [70518202000]

Letrozole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090289
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-15

Drug Details

Active Ingredients

IngredientStrength
LETROZOLE2.5 mg/1

OpenFDA Data

SPL SET ID:27e5a748-7db9-42be-866a-352066cc159f
Manufacturer
UNII

Pharmacological Class

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