FDA.reportPublic FDA data

CINACALCET

Product NDC
76282-676
11-digit product format
762820676
Labeler code
76282
Product ID
76282-676_d4eda09a-6371-49ea-bc20-054b55e432e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CINACALCET
Dosage form
TABLET
Route
ORAL
Labeler
EXELAN PHARMACEUTICALS INC.
Application
ANDA208915
Marketing category
ANDA
Marketing start
2020-04-14
Substance
CINACALCET HYDROCHLORIDE
Active strength
90 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CINACALCET HYDROCHLORIDE90 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1K860WSG25
Rxcui432400, 432401, 432402

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
77d7bb05-5b36-6931-a2f8-2f1eeddcdb03Product name320181011

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-676-30CINACALCET30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-676-30EA - Each76282-6764b00ab88-4b5e-4964-8061-ba4f34c8f89012020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-676CINACALCET TABLET [EXELAN PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 1 package rows20200415_04a978cb-d57b-4f1e-ba14-316b6f9abe33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432402cinacalcet HCl 30 MG Oral TabletPSN04a978cb-d57b-4f1e-ba14-316b6f9abe331
432401cinacalcet HCl 60 MG Oral TabletPSN04a978cb-d57b-4f1e-ba14-316b6f9abe331
432400cinacalcet HCl 90 MG Oral TabletPSN04a978cb-d57b-4f1e-ba14-316b6f9abe331
432402cinacalcet 30 MG Oral TabletSCD04a978cb-d57b-4f1e-ba14-316b6f9abe331
432401cinacalcet 60 MG Oral TabletSCD04a978cb-d57b-4f1e-ba14-316b6f9abe331
432400cinacalcet 90 MG Oral TabletSCD04a978cb-d57b-4f1e-ba14-316b6f9abe331
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY04a978cb-d57b-4f1e-ba14-316b6f9abe331
432401cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral TabletSY04a978cb-d57b-4f1e-ba14-316b6f9abe331
432400cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral TabletSY04a978cb-d57b-4f1e-ba14-316b6f9abe331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-676-307628206763030 TABLET in 1 BOTTLE (76282-676-30) 30 tablet2020-04-140000-00-00NoNoCurrent