FDA.reportPublic FDA data

Cinacalcet

Product NDC
31722-104
11-digit product format
317220104
Labeler code
31722
Product ID
31722-104_5480ebd3-5b39-4f8b-bb03-05617f6f519f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cinacalcet
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA209403
Marketing category
ANDA
Marketing start
2020-10-07
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CINACALCET HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1K860WSG25
Rxcui432400, 432401, 432402

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
31722-104-30Cinacalcet30 in 1 BOTTLETABLET, FILM COATED301
31722-104-31Cinacalcet10 in 1 BLISTER PACKTABLET, FILM COATED101
31722-104-31Cinacalcet3 in 1 CARTONTABLET, FILM COATED31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-104CINACALCET TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 3 package rows20201013_5480ebd3-5b39-4f8b-bb03-05617f6f519f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432402cinacalcet HCl 30 MG Oral TabletPSN5480ebd3-5b39-4f8b-bb03-05617f6f519f1
432401cinacalcet HCl 60 MG Oral TabletPSN5480ebd3-5b39-4f8b-bb03-05617f6f519f1
432400cinacalcet HCl 90 MG Oral TabletPSN5480ebd3-5b39-4f8b-bb03-05617f6f519f1
432402cinacalcet 30 MG Oral TabletSCD5480ebd3-5b39-4f8b-bb03-05617f6f519f1
432401cinacalcet 60 MG Oral TabletSCD5480ebd3-5b39-4f8b-bb03-05617f6f519f1
432400cinacalcet 90 MG Oral TabletSCD5480ebd3-5b39-4f8b-bb03-05617f6f519f1
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY5480ebd3-5b39-4f8b-bb03-05617f6f519f1
432401cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral TabletSY5480ebd3-5b39-4f8b-bb03-05617f6f519f1
432400cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral TabletSY5480ebd3-5b39-4f8b-bb03-05617f6f519f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-104-303172201043030 TABLET, FILM COATED in 1 BOTTLE (31722-104-30) 2020-10-070000-00-00NoNoCurrent
31722-104-31317220104313 BLISTER PACK in 1 CARTON (31722-104-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2020-10-070000-00-00NoNoCurrent