cinacalcet hydrochloride

Product NDC
70436-007
11-digit product format
704360007
Labeler code
70436
Product ID
70436-007_c1846376-f8b3-4868-95c6-7475cd354eea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cinacalcet hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Slate Run Pharmaceuticals
Application
ANDA210207
Marketing category
ANDA
Marketing start
2019-03-06
Marketing end
0000-00-00
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
2021-12-31
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
70436-007-04cinacalcet hydrochloride30 in 1 BOTTLETABLET, FILM COATED3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-007-04EA - Each70436-007d4c837f7-c727-425e-925d-c620839a2b6512019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-007CINACALCET HYDROCHLORIDE TABLET, FILM COATED [SLATE RUN PHARMACEUTICALS]10Legacy NDC, 1 package rows20240913_0850ec78-ae46-481e-a6b5-8169cb843eab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432402cinacalcet HCl 30 MG Oral TabletPSN0850ec78-ae46-481e-a6b5-8169cb843eab10
432401cinacalcet HCl 60 MG Oral TabletPSN0850ec78-ae46-481e-a6b5-8169cb843eab10
432400cinacalcet HCl 90 MG Oral TabletPSN0850ec78-ae46-481e-a6b5-8169cb843eab10
432402cinacalcet 30 MG Oral TabletSCD0850ec78-ae46-481e-a6b5-8169cb843eab10
432401cinacalcet 60 MG Oral TabletSCD0850ec78-ae46-481e-a6b5-8169cb843eab10
432400cinacalcet 90 MG Oral TabletSCD0850ec78-ae46-481e-a6b5-8169cb843eab10
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY0850ec78-ae46-481e-a6b5-8169cb843eab10
432401cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral TabletSY0850ec78-ae46-481e-a6b5-8169cb843eab10
432400cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral TabletSY0850ec78-ae46-481e-a6b5-8169cb843eab10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70436-007-047043600070430 TABLET, FILM COATED in 1 BOTTLE (70436-007-04) 2019-03-060000-00-00NoNoCurrent