NDC 70710-1002

Cinacalcet

Cinacalcet

Cinacalcet is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Cinacalcet Hydrochloride.

Product ID70710-1002_064619cc-17a3-40d2-9f0a-be23eb5805a7
NDC70710-1002
Product TypeHuman Prescription Drug
Proprietary NameCinacalcet
Generic NameCinacalcet
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-09-13
Marketing CategoryANDA / ANDA
Application NumberANDA208971
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameCINACALCET HYDROCHLORIDE
Active Ingredient Strength90 mg/1
Pharm ClassesCalcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70710-1002-9

90 TABLET, FILM COATED in 1 BOTTLE (70710-1002-9)
Marketing Start Date2018-09-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70710-1002-9 [70710100209]

Cinacalcet TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208971
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-13
Marketing End Date2018-09-14

NDC 70710-1002-3 [70710100203]

Cinacalcet TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208971
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-13
Marketing End Date2018-09-14

NDC 70710-1002-1 [70710100201]

Cinacalcet TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208971
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-13
Marketing End Date2018-09-14

Drug Details

Active Ingredients

IngredientStrength
CINACALCET HYDROCHLORIDE90 mg/1

OpenFDA Data

SPL SET ID:d7871d04-b2a0-48ca-ac56-dc3ea032ef10
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 432402
  • 432401
  • 432400
    • UPC Code
  • 0370710100032

    • 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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