FDA.reportPublic FDA data

Cinacalcet

Product NDC
67877-503
11-digit product format
678770503
Labeler code
67877
Product ID
67877-503_7dc83b54-a624-48db-ad2d-ee000a6d9c47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cinacalcet
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
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
2027-12-31
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
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
67877-503-01Cinacalcet100 in 1 BOTTLETABLET, FILM COATED10011
67877-503-30Cinacalcet30 in 1 BOTTLETABLET, FILM COATED3011
67877-503-33Cinacalcet10 in 1 BLISTER PACKTABLET, FILM COATED1011
67877-503-33Cinacalcet10 in 1 CARTONTABLET, FILM COATED1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-503CINACALCET TABLET, FILM COATED [ASCEND LABORATORIES, LLC]10Current NDC, Legacy NDC, 4 package rows20220722_55f95ae0-84ac-4ae4-b7a0-7590ab919ae1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432402cinacalcet HCl 30 MG Oral TabletPSN86fe67f9-d4e0-4966-a80b-c04bf6bb0ef9106
432402cinacalcet 30 MG Oral TabletSCD86fe67f9-d4e0-4966-a80b-c04bf6bb0ef9106
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY86fe67f9-d4e0-4966-a80b-c04bf6bb0ef9106
432402cinacalcet HCl 30 MG Oral TabletPSN60e6264c-723c-49b2-a246-827b15ff219c102
432402cinacalcet 30 MG Oral TabletSCD60e6264c-723c-49b2-a246-827b15ff219c102
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY60e6264c-723c-49b2-a246-827b15ff219c102
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
432402cinacalcet HCl 30 MG Oral TabletPSN55f95ae0-84ac-4ae4-b7a0-7590ab919ae111
432401cinacalcet HCl 60 MG Oral TabletPSN55f95ae0-84ac-4ae4-b7a0-7590ab919ae111
432400cinacalcet HCl 90 MG Oral TabletPSN55f95ae0-84ac-4ae4-b7a0-7590ab919ae111
432402cinacalcet 30 MG Oral TabletSCD55f95ae0-84ac-4ae4-b7a0-7590ab919ae111
432401cinacalcet 60 MG Oral TabletSCD55f95ae0-84ac-4ae4-b7a0-7590ab919ae111
432400cinacalcet 90 MG Oral TabletSCD55f95ae0-84ac-4ae4-b7a0-7590ab919ae111
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY55f95ae0-84ac-4ae4-b7a0-7590ab919ae111
432401cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral TabletSY55f95ae0-84ac-4ae4-b7a0-7590ab919ae111
432400cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral TabletSY55f95ae0-84ac-4ae4-b7a0-7590ab919ae111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-503-0167877050301100 TABLET, FILM COATED in 1 BOTTLE (67877-503-01) 2019-05-180000-00-00NoNoCurrent
67877-503-306787705033030 TABLET, FILM COATED in 1 BOTTLE (67877-503-30) 2019-05-180000-00-00NoNoCurrent
67877-503-336787705033310 BLISTER PACK in 1 CARTON (67877-503-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2019-05-180000-00-00NoNoCurrent