NDC 0378-6197

Cinacalcet Hydrochloride

Cinacalcet Hydrochloride

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

Product ID0378-6197_04a3cc67-330c-4c1a-9f5f-b52ca8b85f89
NDC0378-6197
Product TypeHuman Prescription Drug
Proprietary NameCinacalcet Hydrochloride
Generic NameCinacalcet Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-05-23
Marketing CategoryANDA / ANDA
Application NumberANDA203422
Labeler NameMylan Pharmaceuticals Inc.
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 Through2020-12-31

Packaging

NDC 0378-6197-93

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6197-93)
Marketing Start Date2019-05-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-6197-93 [00378619793]

Cinacalcet TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203422
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-23

Drug Details

Active Ingredients

IngredientStrength
CINACALCET HYDROCHLORIDE30 mg/1

OpenFDA Data

SPL SET ID:0ead1925-2ca3-460b-a140-66f18331e788
Manufacturer
UNII
UPC Code
  • 0303786196937
  • 0303786197934
  • 0303786195930

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    65162-155Cinacalcet HydrochlorideCinacalcet
    65162-157Cinacalcet HydrochlorideCinacalcet
    70436-007cinacalcet hydrochloridecinacalcet hydrochloride
    70436-008cinacalcet hydrochloridecinacalcet hydrochloride
    70436-009cinacalcet hydrochloridecinacalcet hydrochloride
    50090-3529Sensiparcinacalcet hydrochloride
    50090-4470Sensiparcinacalcet hydrochloride
    53808-0577Sensiparcinacalcet hydrochloride
    53808-0578Sensiparcinacalcet hydrochloride
    55513-073Sensiparcinacalcet hydrochloride
    55513-074Sensiparcinacalcet hydrochloride
    55513-075Sensiparcinacalcet hydrochloride
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