NDC 70436-008

cinacalcet hydrochloride

Cinacalcet Hydrochloride

cinacalcet hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Slate Run Pharmaceuticals. The primary component is Cinacalcet Hydrochloride.

Product ID70436-008_0d8c60b4-a0c7-44f3-8e0e-92f3e9e06e56
NDC70436-008
Product TypeHuman Prescription Drug
Proprietary Namecinacalcet hydrochloride
Generic NameCinacalcet Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-03-06
Marketing CategoryANDA / ANDA
Application NumberANDA210207
Labeler NameSlate Run Pharmaceuticals
Substance NameCINACALCET HYDROCHLORIDE
Active Ingredient Strength60 mg/1
Pharm ClassesCalcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70436-008-04

30 TABLET, FILM COATED in 1 BOTTLE (70436-008-04)
Marketing Start Date2019-03-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70436-008-04 [70436000804]

cinacalcet hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210207
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-06

Drug Details

Active Ingredients

IngredientStrength
CINACALCET HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:0850ec78-ae46-481e-a6b5-8169cb843eab
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 432402
  • 432401
  • 432400
    • UPC Code
  • 0370436009046

    • Pharmacological Class

    • Calcium-sensing Receptor Agonist [EPC]
    • Increased Calcium-sensing Receptor Sensitivity [MoA]

    NDC Crossover Matching brand name "cinacalcet hydrochloride" or generic name "Cinacalcet Hydrochloride"

    NDCBrand NameGeneric Name
    0378-6195Cinacalcet HydrochlorideCinacalcet Hydrochloride
    0378-6196Cinacalcet HydrochlorideCinacalcet Hydrochloride
    0378-6197Cinacalcet HydrochlorideCinacalcet Hydrochloride
    0591-2416Cinacalcet HydrochlorideCinacalcet Hydrochloride
    0591-2417Cinacalcet HydrochlorideCinacalcet Hydrochloride
    0591-2418Cinacalcet HydrochlorideCinacalcet Hydrochloride
    64380-883Cinacalcet HydrochlorideCinacalcet Hydrochloride
    64380-884Cinacalcet HydrochlorideCinacalcet Hydrochloride
    64380-885Cinacalcet HydrochlorideCinacalcet Hydrochloride
    65162-155Cinacalcet HydrochlorideCinacalcet
    65162-157Cinacalcet HydrochlorideCinacalcet
    70436-007cinacalcet hydrochloridecinacalcet hydrochloride
    70436-008cinacalcet hydrochloridecinacalcet hydrochloride
    70436-009cinacalcet hydrochloridecinacalcet hydrochloride
    50090-3529Sensiparcinacalcet hydrochloride
    50090-4470Sensiparcinacalcet hydrochloride
    53808-0577Sensiparcinacalcet hydrochloride
    53808-0578Sensiparcinacalcet hydrochloride
    55513-073Sensiparcinacalcet hydrochloride
    55513-074Sensiparcinacalcet hydrochloride
    55513-075Sensiparcinacalcet hydrochloride
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