FDA.reportPublic FDA data

Cinacalcet

Product NDC
64380-883
11-digit product format
643800883
Labeler code
64380
Product ID
64380-883_40332509-df24-41a0-a75c-86d556cf0c50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cinacalcet
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA209226
Marketing category
ANDA
Marketing start
2019-07-16
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
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
64380-883-04Cinacalcet30 in 1 BOTTLETABLET, FILM COATED3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-883-04EA - Each64380-883de4f3f7f-ff87-46de-9035-0700dcaf7bec12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-883CINACALCET TABLET, FILM COATED [STRIDES PHARMA SCIENCE LIMITED]14Current NDC, Legacy NDC, 1 package rows20200717_0ba47b6a-ba49-4d7a-82e1-1c6e49bfa5d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432402cinacalcet HCl 30 MG Oral TabletPSN0ba47b6a-ba49-4d7a-82e1-1c6e49bfa5d716
432401cinacalcet HCl 60 MG Oral TabletPSN0ba47b6a-ba49-4d7a-82e1-1c6e49bfa5d716
432400cinacalcet HCl 90 MG Oral TabletPSN0ba47b6a-ba49-4d7a-82e1-1c6e49bfa5d716
432402cinacalcet 30 MG Oral TabletSCD0ba47b6a-ba49-4d7a-82e1-1c6e49bfa5d716
432401cinacalcet 60 MG Oral TabletSCD0ba47b6a-ba49-4d7a-82e1-1c6e49bfa5d716
432400cinacalcet 90 MG Oral TabletSCD0ba47b6a-ba49-4d7a-82e1-1c6e49bfa5d716
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY0ba47b6a-ba49-4d7a-82e1-1c6e49bfa5d716
432401cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral TabletSY0ba47b6a-ba49-4d7a-82e1-1c6e49bfa5d716
432400cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral TabletSY0ba47b6a-ba49-4d7a-82e1-1c6e49bfa5d716
432402cinacalcet HCl 30 MG Oral TabletPSN0692252e-4cc6-4f16-8a54-aeacd59c31432
432402cinacalcet 30 MG Oral TabletSCD0692252e-4cc6-4f16-8a54-aeacd59c31432
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY0692252e-4cc6-4f16-8a54-aeacd59c31432
432402cinacalcet HCl 30 MG Oral TabletPSN1c78bfff-7a82-4d1d-bc61-718c3ff3aa921
432402cinacalcet HCl 30 MG Oral TabletPSN44b548ef-1679-4d15-86ad-0d9636b48a451
432402cinacalcet HCl 30 MG Oral TabletPSN4d2f2a92-ee1c-084a-e063-6294a90aae961
432402cinacalcet 30 MG Oral TabletSCD1c78bfff-7a82-4d1d-bc61-718c3ff3aa921
432402cinacalcet 30 MG Oral TabletSCD44b548ef-1679-4d15-86ad-0d9636b48a451
432402cinacalcet 30 MG Oral TabletSCD4d2f2a92-ee1c-084a-e063-6294a90aae961
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY1c78bfff-7a82-4d1d-bc61-718c3ff3aa921
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY44b548ef-1679-4d15-86ad-0d9636b48a451
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY4d2f2a92-ee1c-084a-e063-6294a90aae961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64380-883-046438008830430 TABLET, FILM COATED in 1 BOTTLE (64380-883-04) 2019-07-160000-00-00NoNoCurrent