FDA.reportPublic FDA data

Cinacalcet

Product NDC
43598-368
11-digit product format
435980368
Labeler code
43598
Product ID
43598-368_b6dbd55a-a71d-0cf8-2c73-7ebbfc032906
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cinacalcet
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddys Laboratories Inc
Application
ANDA208368
Marketing category
ANDA
Marketing start
2020-09-18
Marketing end
2026-11-30
Substance
CINACALCET HYDROCHLORIDE
Active strength
60 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
Cinacalcet

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CINACALCET HYDROCHLORIDE60 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
43598-368-05Cinacalcet500 in 1 BOTTLETABLET50011
43598-368-30Cinacalcet30 in 1 BOTTLETABLET3011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-368CINACALCET TABLET [DR. REDDYS LABORATORIES INC]11Current NDC, Legacy NDC, 2 package rows20240413_0837aabc-e796-0e07-8958-71f1ff6e89bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432402cinacalcet HCl 30 MG Oral TabletPSN0837aabc-e796-0e07-8958-71f1ff6e89bf11
432401cinacalcet HCl 60 MG Oral TabletPSN0837aabc-e796-0e07-8958-71f1ff6e89bf11
432400cinacalcet HCl 90 MG Oral TabletPSN0837aabc-e796-0e07-8958-71f1ff6e89bf11
432402cinacalcet 30 MG Oral TabletSCD0837aabc-e796-0e07-8958-71f1ff6e89bf11
432401cinacalcet 60 MG Oral TabletSCD0837aabc-e796-0e07-8958-71f1ff6e89bf11
432400cinacalcet 90 MG Oral TabletSCD0837aabc-e796-0e07-8958-71f1ff6e89bf11
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY0837aabc-e796-0e07-8958-71f1ff6e89bf11
432401cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral TabletSY0837aabc-e796-0e07-8958-71f1ff6e89bf11
432400cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral TabletSY0837aabc-e796-0e07-8958-71f1ff6e89bf11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-368-0543598036805500 TABLET in 1 BOTTLE (43598-368-05) 500 tablet2020-09-182026-11-30NoNoCurrent
43598-368-304359803683030 TABLET in 1 BOTTLE (43598-368-30) 30 tablet2020-09-182026-11-30NoNoCurrent