Cinacalcet

Product NDC
72162-1843
11-digit product format
721621843
Labeler code
72162
Product ID
72162-1843_310a6668-6a7c-4846-95e4-327e2ab58bff
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
30 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 HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1K860WSG25
Rxcui432402

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
72162-1843-3Cinacalcet30 in 1 BOTTLETABLET, FILM COATED30100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1843-3EA - Each72162-1843923e77ac-d1fa-42cc-b582-cabdccb13ffe12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1843CINACALCET TABLET, FILM COATED [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240310_330b4214-dba7-468c-a67e-b1057f4628da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432402cinacalcet HCl 30 MG Oral TabletPSN330b4214-dba7-468c-a67e-b1057f4628da100
432402cinacalcet 30 MG Oral TabletSCD330b4214-dba7-468c-a67e-b1057f4628da100
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY330b4214-dba7-468c-a67e-b1057f4628da100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1843-37216218430330 TABLET, FILM COATED in 1 BOTTLE (72162-1843-3) 2024-03-08NoNoCurrent