NDC 65862-831

Cinacalcet

Cinacalcet

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

Product ID65862-831_0267a9d5-2a35-436b-a67e-ab7d2d0a6cfb
NDC65862-831
Product TypeHuman Prescription Drug
Proprietary NameCinacalcet
Generic NameCinacalcet
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-06-25
Marketing CategoryANDA / ANDA
Application NumberANDA206125
Labeler NameAurobindo Pharma Limited
Substance NameCINACALCET HYDROCHLORIDE
Active Ingredient Strength30 mg/1
Pharm ClassesCalcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 65862-831-01

100 TABLET, FILM COATED in 1 BOTTLE (65862-831-01)
Marketing Start Date2019-06-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-831-90 [65862083190]

Cinacalcet TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206125
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-25

NDC 65862-831-01 [65862083101]

Cinacalcet TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206125
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-25

NDC 65862-831-30 [65862083130]

Cinacalcet TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206125
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-25

NDC 65862-831-05 [65862083105]

Cinacalcet TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206125
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-25

Drug Details

Active Ingredients

IngredientStrength
CINACALCET HYDROCHLORIDE30 mg/1

OpenFDA Data

SPL SET ID:42e99112-c402-4662-877f-9e3a84dff9f2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 432402
  • 432401
  • 432400
  • 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
    43598-369CinacalcetCinacalcet
    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

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