Cinacalcet

Product NDC
70710-1001
11-digit product format
707101001
Labeler code
70710
Product ID
70710-1001_064619cc-17a3-40d2-9f0a-be23eb5805a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cinacalcet
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA208971
Marketing category
ANDA
Marketing start
2018-09-13
Marketing end
0000-00-00
Substance
CINACALCET HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77d7bb05-5b36-6931-a2f8-2f1eeddcdb03Product name320181011

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1001-1Cinacalcet100 in 1 BOTTLETABLET, FILM COATED1003
70710-1001-3Cinacalcet30 in 1 BOTTLETABLET, FILM COATED303
70710-1001-9Cinacalcet90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1001CINACALCET TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]3Legacy NDC, 3 package rows20180913_d7871d04-b2a0-48ca-ac56-dc3ea032ef10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432402cinacalcet HCl 30 MG Oral TabletPSNd7871d04-b2a0-48ca-ac56-dc3ea032ef103
432401cinacalcet HCl 60 MG Oral TabletPSNd7871d04-b2a0-48ca-ac56-dc3ea032ef103
432400cinacalcet HCl 90 MG Oral TabletPSNd7871d04-b2a0-48ca-ac56-dc3ea032ef103
432402cinacalcet 30 MG Oral TabletSCDd7871d04-b2a0-48ca-ac56-dc3ea032ef103
432401cinacalcet 60 MG Oral TabletSCDd7871d04-b2a0-48ca-ac56-dc3ea032ef103
432400cinacalcet 90 MG Oral TabletSCDd7871d04-b2a0-48ca-ac56-dc3ea032ef103
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSYd7871d04-b2a0-48ca-ac56-dc3ea032ef103
432401cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral TabletSYd7871d04-b2a0-48ca-ac56-dc3ea032ef103
432400cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral TabletSYd7871d04-b2a0-48ca-ac56-dc3ea032ef103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
70710-1001-170710100101100 in 1 BOTTLEHistorical
70710-1001-37071010010330 in 1 BOTTLEHistorical
70710-1001-97071010010990 in 1 BOTTLEHistorical