CINACALCET

Product NDC
71335-2763
11-digit product format
713352763
Labeler code
71335
Product ID
71335-2763_20b7a2f2-f774-4fd6-9e14-b0339d712b07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CINACALCET
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208915
Marketing category
ANDA
Marketing start
2018-03-08
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
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 HYDROCHLORIDE90 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1K860WSG25
Rxcui432400

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
71335-2763-1CINACALCET30 in 1 BOTTLETABLET30100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2763-1EA - Each71335-27634871661c-d635-4f1e-8260-aed37831427712025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432400cinacalcet HCl 90 MG Oral TabletPSN8b6b3867-9c89-4b6d-b381-dc73e1502821100
432400cinacalcet 90 MG Oral TabletSCD8b6b3867-9c89-4b6d-b381-dc73e1502821100
432400cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral TabletSY8b6b3867-9c89-4b6d-b381-dc73e1502821100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2763-17133527630130 TABLET in 1 BOTTLE (71335-2763-1) 30 tablet2025-08-08NoNoCurrent