NDC 47335-380

Cinacalcet

Cinacalcet

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

Product ID47335-380_0c42c651-2704-4e70-95e7-6fb60abdaf25
NDC47335-380
Product TypeHuman Prescription Drug
Proprietary NameCinacalcet
Generic NameCinacalcet
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-05-15
Marketing CategoryANDA / ANDA
Application NumberANDA207008
Labeler NameSun Pharmaceutical Industries, Inc.
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 Through2021-12-31

Packaging

NDC 47335-380-83

30 TABLET, FILM COATED in 1 BOTTLE (47335-380-83)
Marketing Start Date2019-05-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47335-380-88 [47335038088]

Cinacalcet TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207008
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-15
Marketing End Date2019-08-03

NDC 47335-380-83 [47335038083]

Cinacalcet TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207008
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-15

NDC 47335-380-18 [47335038018]

Cinacalcet TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207008
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-15
Marketing End Date2019-08-03

Drug Details

Active Ingredients

IngredientStrength
CINACALCET HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:092553cf-1bcd-4c19-9adf-b46f2bda5c9e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 432402
  • 432401
  • 432400
    • UPC Code
  • 0347335380835
  • 0347335600834

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0378-6195CinacalcetCinacalcet
    0378-6196CinacalcetCinacalcet
    0378-6197CinacalcetCinacalcet
    0904-7067CinacalcetCinacalcet
    16714-078CinacalcetCinacalcet
    16714-079CinacalcetCinacalcet
    16714-080CinacalcetCinacalcet
    16729-440CINACALCETCinacalcet
    16729-441CINACALCETCinacalcet
    16729-442CINACALCETCinacalcet
    31722-103CinacalcetCinacalcet
    31722-104CinacalcetCinacalcet
    31722-105CinacalcetCinacalcet
    42291-459CinacalcetCinacalcet
    42291-460CinacalcetCinacalcet
    42291-461CinacalcetCinacalcet
    42543-961CinacalcetCinacalcet
    42543-962CinacalcetCinacalcet
    42543-963CinacalcetCinacalcet
    43598-367CinacalcetCinacalcet
    43598-368CinacalcetCinacalcet
    69097-410CINACALCETCINACALCET
    69097-411CINACALCETCINACALCET
    69097-412CINACALCETCINACALCET
    70710-1002CinacalcetCinacalcet
    70710-1000CinacalcetCinacalcet
    70771-1054CinacalcetCinacalcet
    70771-1055CinacalcetCinacalcet
    70771-1056CinacalcetCinacalcet
    70710-1001CinacalcetCinacalcet
    47335-600CinacalcetCinacalcet
    47335-380CinacalcetCinacalcet
    47335-379CinacalcetCinacalcet
    67877-504CinacalcetCinacalcet
    67877-505CinacalcetCinacalcet
    67877-503CinacalcetCinacalcet
    65862-832CinacalcetCinacalcet
    65862-831CinacalcetCinacalcet
    65862-833CinacalcetCinacalcet
    60687-525CinacalcetCinacalcet
    76282-674CINACALCETCINACALCET
    76282-676CINACALCETCINACALCET
    76282-675CINACALCETCINACALCET
    43598-369CinacalcetCinacalcet
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