NDC 16714-079

Cinacalcet

Cinacalcet

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

Product ID16714-079_1bd0cd10-6496-42fe-a571-758af052d358
NDC16714-079
Product TypeHuman Prescription Drug
Proprietary NameCinacalcet
Generic NameCinacalcet
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-02-27
Marketing CategoryANDA / ANDA
Application NumberANDA207008
Labeler NameNorthStar RxLLC
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 Through2023-12-31

Packaging

NDC 16714-079-01

30 TABLET, FILM COATED in 1 BOTTLE (16714-079-01)
Marketing Start Date2020-02-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16714-079-01 [16714007901]

Cinacalcet TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207008
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-27

Drug Details

Active Ingredients

IngredientStrength
CINACALCET HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:aa09a7e0-d2e6-444b-961b-d740f32d9297
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 432402
  • 432401
  • 432400
  • UPC Code
  • 0316714079011
  • 0316714078014
  • Pharmacological Class

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

    Medicade Reported Pricing

    16714079904 CETIRIZINE HCL 10 MG TABLET

    Pricing Unit: EA | Drug Type:

    16714079903 CETIRIZINE HCL 10 MG TABLET

    Pricing Unit: EA | Drug Type:

    16714079902 CETIRIZINE HCL 10 MG TABLET

    Pricing Unit: EA | Drug Type:

    16714079901 CETIRIZINE HCL 10 MG TABLET

    Pricing Unit: EA | Drug Type:

    16714079801 SUMATRIPTAN SUCC 100 MG TABLET

    Pricing Unit: EA | Drug Type:

    16714079701 SUMATRIPTAN SUCC 50 MG TABLET

    Pricing Unit: EA | Drug Type:

    16714079601 SUMATRIPTAN SUCC 25 MG TABLET

    Pricing Unit: EA | Drug Type:

    16714079502 TERBINAFINE HCL 250 MG TABLET

    Pricing Unit: EA | Drug Type:

    16714079501 TERBINAFINE HCL 250 MG TABLET

    Pricing Unit: EA | Drug Type:

    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.