FDA.reportPublic FDA data

Cinacalcet

Product NDC
72865-150
11-digit product format
728650150
Labeler code
72865
Product ID
72865-150_f26f3bd0-cfac-0d57-e053-2995a90aa96a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cinacalcet
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
XLCare Pharmaceuticals Inc.
Application
ANDA209403
Marketing category
ANDA
Marketing start
2021-02-16
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CINACALCET HYDROCHLORIDE30 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
72865-150-30Cinacalcet30 in 1 BOTTLETABLET, FILM COATED302
72865-150-31Cinacalcet3 in 1 CARTONTABLET, FILM COATED32
72865-150-31Cinacalcet10 in 1 BLISTER PACKTABLET, FILM COATED102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-150-30EA - Each72865-1503f1f6fd3-ea56-4adb-8e7d-d31748cc340512021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-150CINACALCET (CINACALCET) TABLET, FILM COATED [XLCARE PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 3 package rows20230117_ff0b9500-085a-4e1e-a2e4-fd918ed70b2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432402cinacalcet HCl 30 MG Oral TabletPSNff0b9500-085a-4e1e-a2e4-fd918ed70b2e2
432401cinacalcet HCl 60 MG Oral TabletPSNff0b9500-085a-4e1e-a2e4-fd918ed70b2e2
432400cinacalcet HCl 90 MG Oral TabletPSNff0b9500-085a-4e1e-a2e4-fd918ed70b2e2
432402cinacalcet 30 MG Oral TabletSCDff0b9500-085a-4e1e-a2e4-fd918ed70b2e2
432401cinacalcet 60 MG Oral TabletSCDff0b9500-085a-4e1e-a2e4-fd918ed70b2e2
432400cinacalcet 90 MG Oral TabletSCDff0b9500-085a-4e1e-a2e4-fd918ed70b2e2
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSYff0b9500-085a-4e1e-a2e4-fd918ed70b2e2
432401cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral TabletSYff0b9500-085a-4e1e-a2e4-fd918ed70b2e2
432400cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral TabletSYff0b9500-085a-4e1e-a2e4-fd918ed70b2e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72865-150-307286501503030 TABLET, FILM COATED in 1 BOTTLE (72865-150-30) 2021-02-160000-00-00NoNoCurrent
72865-150-31728650150313 BLISTER PACK in 1 CARTON (72865-150-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2021-02-160000-00-00NoNoCurrent