Cinacalcet

Product NDC
72162-1845
11-digit product format
721621845
Labeler code
72162
Product ID
72162-1845_0ed29d43-28a1-40fa-bf90-9ec805d62780
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
72162-1845-3Cinacalcet30 in 1 BOTTLETABLET, FILM COATED30100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1845-3EA - Each72162-1845e3de14f0-bdcb-418c-a7d5-4df06d0056e512024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1845CINACALCET TABLET, FILM COATED [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240310_f1cfc943-5b70-4451-a1fc-61e45e669d84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432400cinacalcet HCl 90 MG Oral TabletPSNf1cfc943-5b70-4451-a1fc-61e45e669d84100
432400cinacalcet 90 MG Oral TabletSCDf1cfc943-5b70-4451-a1fc-61e45e669d84100
432400cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral TabletSYf1cfc943-5b70-4451-a1fc-61e45e669d84100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1845-37216218450330 TABLET, FILM COATED in 1 BOTTLE (72162-1845-3) 2024-03-08NoNoCurrent