NDC 64380-884

Cinacalcet Hydrochloride

Cinacalcet Hydrochloride

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

Product ID64380-884_1351e2d5-f8cd-4fca-80c5-e1a648774c72
NDC64380-884
Product TypeHuman Prescription Drug
Proprietary NameCinacalcet Hydrochloride
Generic NameCinacalcet Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-06-05
Marketing CategoryANDA / ANDA
Application NumberANDA209226
Labeler NameStrides Pharma Science Limited
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 Through2020-12-31

Packaging

NDC 64380-884-04

30 TABLET, FILM COATED in 1 BOTTLE (64380-884-04)
Marketing Start Date2019-08-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64380-884-04 [64380088404]

Cinacalcet Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209226
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-22

Drug Details

Active Ingredients

IngredientStrength
CINACALCET HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:0ba47b6a-ba49-4d7a-82e1-1c6e49bfa5d7
Manufacturer
UNII

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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