CINACALCET

Product NDC
71335-2761
11-digit product format
713352761
Labeler code
71335
Product ID
71335-2761_e9aa2878-9daf-47a1-b20c-f0d4d992acf5
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
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

Related Records

Active Ingredients

IngredientStrength
CINACALCET HYDROCHLORIDE30 mg/1

Harmonized Identifiers

FieldValues
Unii1K860WSG25
Rxcui432402

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
1K860WSG25CINACALCET HYDROCHLORIDE364782-34-3CINACALCET HYDROCHLORIDE
UAZ6V7728SCINACALCET226256-56-0CINACALCET

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2761-17133527610130 TABLET in 1 BOTTLE (71335-2761-1) 30 tablet2025-08-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CINACALCETBryant Ranch Prepack2025-08-08HUMAN PRESCRIPTION DRUG LABEL100