Cinacalcet

Product NDC
63629-9606
11-digit product format
636299606
Labeler code
63629
Product ID
63629-9606_b4a4056d-3b6c-467d-bedf-857713da6cef
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
63629-9606-1Cinacalcet30 in 1 BOTTLETABLET, FILM COATED30102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9606-1EA - Each63629-9606b02298e4-9400-4d48-8f7d-95717e57965212023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9606CINACALCET TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240423_b920a91f-309f-4f83-a123-525b3bdd55b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432400cinacalcet HCl 90 MG Oral TabletPSNb920a91f-309f-4f83-a123-525b3bdd55b7102
432400cinacalcet 90 MG Oral TabletSCDb920a91f-309f-4f83-a123-525b3bdd55b7102
432400cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral TabletSYb920a91f-309f-4f83-a123-525b3bdd55b7102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-9606-16362996060130 TABLET, FILM COATED in 1 BOTTLE (63629-9606-1) 2022-12-280000-00-00NoNoCurrent