NDC 0591-2416

Cinacalcet Hydrochloride

Cinacalcet Hydrochloride

Cinacalcet Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Cinacalcet Hydrochloride.

Product ID0591-2416_c0e98237-6c99-4402-942b-e702073f1feb
NDC0591-2416
Product TypeHuman Prescription Drug
Proprietary NameCinacalcet Hydrochloride
Generic NameCinacalcet Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-12-27
Marketing End Date2020-06-30
Marketing CategoryANDA / ANDA
Application NumberANDA204377
Labeler NameActavis Pharma, Inc.
Substance NameCINACALCET HYDROCHLORIDE
Active Ingredient Strength30 mg/1
Pharm ClassesCalcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]
NDC Exclude FlagN

Packaging

NDC 0591-2416-30

30 TABLET, FILM COATED in 1 BOTTLE (0591-2416-30)
Marketing Start Date2018-12-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-2416-30 [00591241630]

Cinacalcet Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204377
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-27

Drug Details

Active Ingredients

IngredientStrength
CINACALCET HYDROCHLORIDE30 mg/1

OpenFDA Data

SPL SET ID:f3a9db02-5732-48d1-92f5-e2be5a15171e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 432402
  • 432401
  • 432400
  • Pharmacological Class

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