NDC 53808-0578

Sensipar

Cinacalcet Hydrochloride

Sensipar is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by State Of Florida Doh Central Pharmacy. The primary component is Cinacalcet Hydrochloride.

Product ID53808-0578_29dcedcd-efba-436a-8542-99faff58875f
NDC53808-0578
Product TypeHuman Prescription Drug
Proprietary NameSensipar
Generic NameCinacalcet Hydrochloride
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2009-07-01
Marketing CategoryNDA / NDA
Application NumberNDA021688
Labeler NameState of Florida DOH Central Pharmacy
Substance NameCINACALCET HYDROCHLORIDE
Active Ingredient Strength60 mg/1
Pharm ClassesCalcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53808-0578-1

30 TABLET, COATED in 1 BLISTER PACK (53808-0578-1)
Marketing Start Date2009-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53808-0578-1 [53808057801]

Sensipar TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021688
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-01
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
CINACALCET HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:8f390187-1071-4000-b778-1d21c518cc9c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 656137
  • 432402
  • 432401
  • 706958
    • UPC Code
  • 0355513073301
  • 0355513074308

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Sensipar" or generic name "Cinacalcet Hydrochloride"

    NDCBrand NameGeneric Name
    50090-3529Sensiparcinacalcet hydrochloride
    50090-4470Sensiparcinacalcet hydrochloride
    53808-0577Sensiparcinacalcet hydrochloride
    53808-0578Sensiparcinacalcet hydrochloride
    55513-073Sensiparcinacalcet hydrochloride
    55513-074Sensiparcinacalcet hydrochloride
    55513-075Sensiparcinacalcet hydrochloride
    68151-4740Sensiparcinacalcet hydrochloride
    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
    70436-007cinacalcet hydrochloridecinacalcet hydrochloride

    Trademark Results [Sensipar]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SENSIPAR
    SENSIPAR
    76200460 2867132 Live/Registered
    Amgen Inc.
    2001-01-26
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