Cinacalcet

Product NDC
63629-8765
11-digit product format
636298765
Labeler code
63629
Product ID
63629-8765_8cdea7f1-29c7-44ae-9044-a6e0f657ddfa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cinacalcet
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210570
Marketing category
ANDA
Marketing start
2019-05-18
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CINACALCET HYDROCHLORIDE90 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1K860WSG25
Rxcui432400

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
63629-8765-1Cinacalcet30 in 1 BOTTLETABLET, FILM COATED30104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8765-1EA - Each63629-8765efa9ae02-a8f8-42dc-99dc-eec1079f756612021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8765CINACALCET TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20231031_b71d56b8-9c03-4347-8752-8a04825a1add.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432400cinacalcet HCl 90 MG Oral TabletPSNb71d56b8-9c03-4347-8752-8a04825a1add105
432400cinacalcet 90 MG Oral TabletSCDb71d56b8-9c03-4347-8752-8a04825a1add105
432400cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral TabletSYb71d56b8-9c03-4347-8752-8a04825a1add105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8765-16362987650130 TABLET, FILM COATED in 1 BOTTLE (63629-8765-1) 2019-05-180000-00-00NoNoCurrent