NDC 66993-142

Aliskiren

Aliskiren Hemifumarate

Aliskiren is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Prasco Laboratories. The primary component is Aliskiren Hemifumarate.

Product ID66993-142_2e7a3fb0-08fd-43dc-8c52-ce9223018e7f
NDC66993-142
Product TypeHuman Prescription Drug
Proprietary NameAliskiren
Generic NameAliskiren Hemifumarate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-03-04
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021985
Labeler NamePrasco Laboratories
Substance NameALISKIREN HEMIFUMARATE
Active Ingredient Strength300 mg/1
Pharm ClassesRenin Inhibitor [EPC],Renin Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 66993-142-30

30 TABLET, FILM COATED in 1 BOTTLE (66993-142-30)
Marketing Start Date2019-03-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66993-142-30 [66993014230]

Aliskiren TABLET, FILM COATED
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA021985
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-04

Drug Details

Active Ingredients

IngredientStrength
ALISKIREN HEMIFUMARATE300 mg/1

OpenFDA Data

SPL SET ID:41c0e5e0-eb26-4d9e-bcd2-d0f2cc8fc6db
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1011739
  • 1011736
  • UPC Code
  • 0366993142302
  • 0366993141305
  • Pharmacological Class

    • Renin Inhibitor [EPC]
    • Renin Inhibitors [MoA]
    • Renin Inhibitor [EPC]
    • Renin Inhibitors [MoA]

    NDC Crossover Matching brand name "Aliskiren" or generic name "Aliskiren Hemifumarate"

    NDCBrand NameGeneric Name
    49884-424ALISKIRENALISKIREN
    49884-425ALISKIRENALISKIREN
    66993-141Aliskirenaliskiren hemifumarate
    66993-142Aliskirenaliskiren hemifumarate
    50090-1250Tekturnaaliskiren hemifumarate
    50090-2985Tekturnaaliskiren hemifumarate
    70839-150Tekturnaaliskiren hemifumarate
    70839-300Tekturnaaliskiren hemifumarate

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