Cinacalcet

Product NDC
63629-9607
11-digit product format
636299607
Labeler code
63629
Product ID
63629-9607_6c62ee47-9c52-451d-ac6c-e4742d0dad48
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
60 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 HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1K860WSG25
Rxcui432401

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
63629-9607-1Cinacalcet30 in 1 BOTTLETABLET, FILM COATED30102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9607-1EA - Each63629-9607a4808860-912d-4d00-8b9e-dad3afcb0fab12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9607CINACALCET TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240403_e96cfada-3763-4af7-b323-1256926a797c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432401cinacalcet HCl 60 MG Oral TabletPSNe96cfada-3763-4af7-b323-1256926a797c102
432401cinacalcet 60 MG Oral TabletSCDe96cfada-3763-4af7-b323-1256926a797c102
432401cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral TabletSYe96cfada-3763-4af7-b323-1256926a797c102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-9607-16362996070130 TABLET, FILM COATED in 1 BOTTLE (63629-9607-1) 2022-12-280000-00-00NoNoCurrent