FDA.reportPublic FDA data

Cinacalcet Hydrochloride

Product NDC
65162-155
11-digit product format
651620155
Labeler code
65162
Product ID
65162-155_4d63252a-b953-4066-b38c-a468580dc407
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cinacalcet
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA204364
Marketing category
ANDA
Marketing start
2021-12-06
Substance
CINACALCET HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cinacalcet Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CINACALCET HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1K860WSG25
Rxcui432400, 432401, 432402

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
77d7bb05-5b36-6931-a2f8-2f1eeddcdb03Product name320181011
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-155-03Cinacalcet Hydrochloride30 in 1 BOTTLETABLET3016
65162-155-10Cinacalcet Hydrochloride100 in 1 BOTTLETABLET10016
65162-155-25Cinacalcet Hydrochloride250 in 1 BOTTLETABLET25016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-155CINACALCET HYDROCHLORIDE (CINACALCET) TABLET [AMNEAL PHARMACEUTICALS LLC]16Current NDC, Legacy NDC, 3 package rows20241027_28262843-b0a8-4ca7-8b92-41b7f0e896b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432402cinacalcet HCl 30 MG Oral TabletPSN28262843-b0a8-4ca7-8b92-41b7f0e896b416
432401cinacalcet HCl 60 MG Oral TabletPSN28262843-b0a8-4ca7-8b92-41b7f0e896b416
432400cinacalcet HCl 90 MG Oral TabletPSN28262843-b0a8-4ca7-8b92-41b7f0e896b416
432402cinacalcet 30 MG Oral TabletSCD28262843-b0a8-4ca7-8b92-41b7f0e896b416
432401cinacalcet 60 MG Oral TabletSCD28262843-b0a8-4ca7-8b92-41b7f0e896b416
432400cinacalcet 90 MG Oral TabletSCD28262843-b0a8-4ca7-8b92-41b7f0e896b416
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY28262843-b0a8-4ca7-8b92-41b7f0e896b416
432401cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral TabletSY28262843-b0a8-4ca7-8b92-41b7f0e896b416
432400cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral TabletSY28262843-b0a8-4ca7-8b92-41b7f0e896b416

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-155-036516201550330 TABLET in 1 BOTTLE (65162-155-03) 30 tablet2021-12-060000-00-00NoNoCurrent
65162-155-1065162015510100 TABLET in 1 BOTTLE (65162-155-10) 100 tablet2021-12-060000-00-00NoNoCurrent
65162-155-2565162015525250 TABLET in 1 BOTTLE (65162-155-25) 250 tablet2021-12-060000-00-00NoNoCurrent