FDA.reportPublic FDA data

Sensipar

Product NDC
55513-073
11-digit product format
555130073
Labeler code
55513
Product ID
55513-073_42c2c9c2-6929-4952-b559-a57a1d75424e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cinacalcet hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Amgen Inc
Application
NDA021688
Marketing category
NDA
Marketing start
2004-04-04
Marketing end
2027-12-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sensipar

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CINACALCET HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1K860WSG25
Rxcui432400, 432401, 432402, 656137, 706958, 706960

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
55513-073-30Sensipar30 in 1 BOTTLE, PLASTICTABLET, COATED30136

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-073-30EA - Each55513-07313729216-5316-4ece-88b6-dc690d9941d512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CINACALCET HYDROCHLORIDEACTIVE INGREDIENT1K860WSG25SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC]124
CINACALCETACTIVE MOIETYUAZ6V7728SSENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC]124
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC]124
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC]124
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC]124
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC]124
POVIDONESINACTIVE INGREDIENTFZ989GH94ESENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC]124
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC]124
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC]124
CINACALCET HYDROCHLORIDEACTIVE INGREDIENT1K860WSG25SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
CINACALCETACTIVE MOIETYUAZ6V7728SSENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ESENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
CINACALCET HYDROCHLORIDEACTIVE INGREDIENT1K860WSG25SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CINACALCET HYDROCHLORIDEACTIVE INGREDIENT1K860WSG25SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]1
CINACALCETACTIVE MOIETYUAZ6V7728SSENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CINACALCETACTIVE MOIETYUAZ6V7728SSENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]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
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ESENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ESENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]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
55513-073SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC]135Current NDC, Legacy NDC, 1 package rows20241115_45028573-13c4-4c8b-ae62-6c75bba97c81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432402cinacalcet HCl 30 MG Oral TabletPSN45028573-13c4-4c8b-ae62-6c75bba97c81136
432401cinacalcet HCl 60 MG Oral TabletPSN45028573-13c4-4c8b-ae62-6c75bba97c81136
432400cinacalcet HCl 90 MG Oral TabletPSN45028573-13c4-4c8b-ae62-6c75bba97c81136
656137Sensipar 30 MG Oral TabletPSN45028573-13c4-4c8b-ae62-6c75bba97c81136
706958Sensipar 60 MG Oral TabletPSN45028573-13c4-4c8b-ae62-6c75bba97c81136
706960Sensipar 90 MG Oral TabletPSN45028573-13c4-4c8b-ae62-6c75bba97c81136
656137cinacalcet 30 MG Oral Tablet [Sensipar]SBD45028573-13c4-4c8b-ae62-6c75bba97c81136
706958cinacalcet 60 MG Oral Tablet [Sensipar]SBD45028573-13c4-4c8b-ae62-6c75bba97c81136
706960cinacalcet 90 MG Oral Tablet [Sensipar]SBD45028573-13c4-4c8b-ae62-6c75bba97c81136
432402cinacalcet 30 MG Oral TabletSCD45028573-13c4-4c8b-ae62-6c75bba97c81136
432401cinacalcet 60 MG Oral TabletSCD45028573-13c4-4c8b-ae62-6c75bba97c81136
432400cinacalcet 90 MG Oral TabletSCD45028573-13c4-4c8b-ae62-6c75bba97c81136
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY45028573-13c4-4c8b-ae62-6c75bba97c81136
432401cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral TabletSY45028573-13c4-4c8b-ae62-6c75bba97c81136
432400cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral TabletSY45028573-13c4-4c8b-ae62-6c75bba97c81136
706960Sensipar (cinacalcet 90 MG) Oral TabletSY45028573-13c4-4c8b-ae62-6c75bba97c81136
656137Sensipar 30 MG (as cinacalcet hydrochloride 33 MG) Oral TabletSY45028573-13c4-4c8b-ae62-6c75bba97c81136
656137Sensipar 30 MG Oral TabletSY45028573-13c4-4c8b-ae62-6c75bba97c81136
706958Sensipar 60 MG (as cinacalcet hydrochloride 66 MG) Oral TabletSY45028573-13c4-4c8b-ae62-6c75bba97c81136
706958Sensipar 60 MG Oral TabletSY45028573-13c4-4c8b-ae62-6c75bba97c81136
706960Sensipar 90 MG Oral TabletSY45028573-13c4-4c8b-ae62-6c75bba97c81136
432402cinacalcet HCl 30 MG Oral TabletPSN8ff022bc-4627-4965-beb1-968deb5b56bc3
656137Sensipar 30 MG Oral TabletPSN8ff022bc-4627-4965-beb1-968deb5b56bc3
656137cinacalcet 30 MG Oral Tablet [Sensipar]SBD8ff022bc-4627-4965-beb1-968deb5b56bc3
432402cinacalcet 30 MG Oral TabletSCD8ff022bc-4627-4965-beb1-968deb5b56bc3
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY8ff022bc-4627-4965-beb1-968deb5b56bc3
656137Sensipar 30 MG (as cinacalcet hydrochloride 33 MG) Oral TabletSY8ff022bc-4627-4965-beb1-968deb5b56bc3
656137Sensipar 30 MG Oral TabletSY8ff022bc-4627-4965-beb1-968deb5b56bc3
432402cinacalcet HCl 30 MG Oral TabletPSNc94c1206-97cb-4088-b8a1-adf08b9387551
432402cinacalcet HCl 30 MG Oral TabletPSN8f390187-1071-4000-b778-1d21c518cc9c1
432401cinacalcet HCl 60 MG Oral TabletPSN8f390187-1071-4000-b778-1d21c518cc9c1
656137Sensipar 30 MG Oral TabletPSNc94c1206-97cb-4088-b8a1-adf08b9387551
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
656137cinacalcet 30 MG Oral Tablet [Sensipar]SBDc94c1206-97cb-4088-b8a1-adf08b9387551
706958cinacalcet 60 MG Oral Tablet [Sensipar]SBD8f390187-1071-4000-b778-1d21c518cc9c1
432402cinacalcet 30 MG Oral TabletSCD8f390187-1071-4000-b778-1d21c518cc9c1
432402cinacalcet 30 MG Oral TabletSCDc94c1206-97cb-4088-b8a1-adf08b9387551
432401cinacalcet 60 MG Oral TabletSCD8f390187-1071-4000-b778-1d21c518cc9c1
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY8f390187-1071-4000-b778-1d21c518cc9c1
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSYc94c1206-97cb-4088-b8a1-adf08b9387551
432401cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral TabletSY8f390187-1071-4000-b778-1d21c518cc9c1
656137Sensipar 30 MG (as cinacalcet hydrochloride 33 MG) Oral TabletSYc94c1206-97cb-4088-b8a1-adf08b9387551
656137Sensipar 30 MG (as cinacalcet hydrochloride 33 MG) Oral TabletSY8f390187-1071-4000-b778-1d21c518cc9c1
656137Sensipar 30 MG Oral TabletSY8f390187-1071-4000-b778-1d21c518cc9c1
656137Sensipar 30 MG Oral TabletSYc94c1206-97cb-4088-b8a1-adf08b9387551
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55513-073-305551300733030 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-073-30) 2004-04-042027-12-31NoNoCurrent