NDC 49884-425

ALISKIREN

Aliskiren

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

Product ID49884-425_c54a494b-ffd9-4502-81bb-96b3e0de7415
NDC49884-425
Product TypeHuman Prescription Drug
Proprietary NameALISKIREN
Generic NameAliskiren
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-03-25
Marketing CategoryANDA / ANDA
Application NumberANDA206665
Labeler NamePar Pharmaceutical, Inc.
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 49884-425-11

30 TABLET, FILM COATED in 1 BOTTLE (49884-425-11)
Marketing Start Date2019-03-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49884-425-11 [49884042511]

ALISKIREN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206665
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-25

Drug Details

Active Ingredients

IngredientStrength
ALISKIREN HEMIFUMARATE300 mg/1

OpenFDA Data

SPL SET ID:f3fd2503-25ef-4660-a29a-f62c491e28fb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1011739
  • 1011736
  • UPC Code
  • 0349884424114
  • 0349884425111
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    49884-424ALISKIRENALISKIREN
    49884-425ALISKIRENALISKIREN
    66993-141Aliskirenaliskiren hemifumarate
    66993-142Aliskirenaliskiren hemifumarate

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