FDA.reportPublic FDA data

Sensipar

Product NDC
53808-0578
11-digit product format
538080578
Labeler code
53808
Product ID
53808-0578_29dcedcd-efba-436a-8542-99faff58875f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cinacalcet hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA021688
Marketing category
NDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
CINACALCET HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77d7bb05-5b36-6931-a2f8-2f1eeddcdb03Product name320181011

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0578-12019-10-21C16284748780-1956f9ecf-db6f-621f-e053-dbdaa90a74adSensipar ® (cinacalcet) Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0578-1Sensipar30 in 1 BLISTER PACKTABLET, COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CINACALCET HYDROCHLORIDEACTIVE INGREDIENT1K860WSG25SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CINACALCETACTIVE MOIETYUAZ6V7728SSENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ESENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0578SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100611_8f390187-1071-4000-b778-1d21c518cc9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432402cinacalcet HCl 30 MG Oral TabletPSN8f390187-1071-4000-b778-1d21c518cc9c1
432401cinacalcet HCl 60 MG Oral TabletPSN8f390187-1071-4000-b778-1d21c518cc9c1
656137Sensipar 30 MG Oral TabletPSN8f390187-1071-4000-b778-1d21c518cc9c1
706958Sensipar 60 MG Oral TabletPSN8f390187-1071-4000-b778-1d21c518cc9c1
656137cinacalcet 30 MG Oral Tablet [Sensipar]SBD8f390187-1071-4000-b778-1d21c518cc9c1
706958cinacalcet 60 MG Oral Tablet [Sensipar]SBD8f390187-1071-4000-b778-1d21c518cc9c1
432402cinacalcet 30 MG Oral TabletSCD8f390187-1071-4000-b778-1d21c518cc9c1
432401cinacalcet 60 MG Oral TabletSCD8f390187-1071-4000-b778-1d21c518cc9c1
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY8f390187-1071-4000-b778-1d21c518cc9c1
432401cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral TabletSY8f390187-1071-4000-b778-1d21c518cc9c1
656137Sensipar 30 MG (as cinacalcet hydrochloride 33 MG) Oral TabletSY8f390187-1071-4000-b778-1d21c518cc9c1
656137Sensipar 30 MG Oral TabletSY8f390187-1071-4000-b778-1d21c518cc9c1
706958Sensipar 60 MG (as cinacalcet hydrochloride 66 MG) Oral TabletSY8f390187-1071-4000-b778-1d21c518cc9c1
706958Sensipar 60 MG Oral TabletSY8f390187-1071-4000-b778-1d21c518cc9c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0578-15380805780130 in 1 BLISTER PACKHistorical