FDA.reportPublic FDA data

Cinacalcet

Product NDC
65862-831
11-digit product format
658620831
Labeler code
65862
Product ID
65862-831_5aadf0b6-2c49-48d4-8d22-2fbf99dbf4e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cinacalcet
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA206125
Marketing category
ANDA
Marketing start
2019-06-25
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
65862-831-01Cinacalcet100 in 1 BOTTLETABLET, FILM COATED1009
65862-831-05Cinacalcet500 in 1 BOTTLETABLET, FILM COATED5009
65862-831-30Cinacalcet30 in 1 BOTTLETABLET, FILM COATED309
65862-831-90Cinacalcet90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-831-05EA - Each65862-831897d42d8-b8fd-4e28-a2e0-13eff5c426f412021-10-08
65862-831-30EA - Each65862-831e6dadf43-a887-4c27-a76c-24afc8f6dee612019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-831CINACALCET TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]9Current NDC, Legacy NDC, 4 package rows20240220_42e99112-c402-4662-877f-9e3a84dff9f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432402cinacalcet HCl 30 MG Oral TabletPSN42e99112-c402-4662-877f-9e3a84dff9f29
432401cinacalcet HCl 60 MG Oral TabletPSN42e99112-c402-4662-877f-9e3a84dff9f29
432400cinacalcet HCl 90 MG Oral TabletPSN42e99112-c402-4662-877f-9e3a84dff9f29
432402cinacalcet 30 MG Oral TabletSCD42e99112-c402-4662-877f-9e3a84dff9f29
432401cinacalcet 60 MG Oral TabletSCD42e99112-c402-4662-877f-9e3a84dff9f29
432400cinacalcet 90 MG Oral TabletSCD42e99112-c402-4662-877f-9e3a84dff9f29
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY42e99112-c402-4662-877f-9e3a84dff9f29
432401cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral TabletSY42e99112-c402-4662-877f-9e3a84dff9f29
432400cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral TabletSY42e99112-c402-4662-877f-9e3a84dff9f29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-831-0165862083101100 TABLET, FILM COATED in 1 BOTTLE (65862-831-01) 2019-06-250000-00-00NoNoCurrent
65862-831-0565862083105500 TABLET, FILM COATED in 1 BOTTLE (65862-831-05) 2019-06-250000-00-00NoNoCurrent
65862-831-306586208313030 TABLET, FILM COATED in 1 BOTTLE (65862-831-30) 2019-06-250000-00-00NoNoCurrent
65862-831-906586208319090 TABLET, FILM COATED in 1 BOTTLE (65862-831-90) 2019-06-250000-00-00NoNoCurrent