FDA.reportPublic FDA data

Cinacalcet

Product NDC
84386-113
11-digit product format
843860113
Labeler code
84386
Product ID
84386-113_200390f2-7dad-4ecc-a086-c29e18525c01
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
2026-03-23
Substance
CINACALCET HYDROCHLORIDE
Active strength
90 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 HYDROCHLORIDE90 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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84386-113-01Cinacalcet100 in 1 BOTTLETABLET, FILM COATED1001
84386-113-05Cinacalcet500 in 1 BOTTLETABLET, FILM COATED5001
84386-113-30Cinacalcet30 in 1 BOTTLETABLET, FILM COATED301
84386-113-90Cinacalcet90 in 1 BOTTLETABLET, FILM COATED901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432402cinacalcet HCl 30 MG Oral TabletPSN200390f2-7dad-4ecc-a086-c29e18525c011
432401cinacalcet HCl 60 MG Oral TabletPSN200390f2-7dad-4ecc-a086-c29e18525c011
432400cinacalcet HCl 90 MG Oral TabletPSN200390f2-7dad-4ecc-a086-c29e18525c011
432402cinacalcet 30 MG Oral TabletSCD200390f2-7dad-4ecc-a086-c29e18525c011
432401cinacalcet 60 MG Oral TabletSCD200390f2-7dad-4ecc-a086-c29e18525c011
432400cinacalcet 90 MG Oral TabletSCD200390f2-7dad-4ecc-a086-c29e18525c011
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY200390f2-7dad-4ecc-a086-c29e18525c011
432401cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral TabletSY200390f2-7dad-4ecc-a086-c29e18525c011
432400cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral TabletSY200390f2-7dad-4ecc-a086-c29e18525c011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84386-113-0184386011301100 TABLET, FILM COATED in 1 BOTTLE (84386-113-01) 2026-03-23NoNoCurrent
84386-113-0584386011305500 TABLET, FILM COATED in 1 BOTTLE (84386-113-05) 2026-03-23NoNoCurrent
84386-113-308438601133030 TABLET, FILM COATED in 1 BOTTLE (84386-113-30) 2026-03-23NoNoCurrent
84386-113-908438601139090 TABLET, FILM COATED in 1 BOTTLE (84386-113-90) 2026-03-23NoNoCurrent