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

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2763-17133527630130 TABLET in 1 BOTTLE (71335-2763-1) 30 tablet2025-08-08NoNoHistorical

Related DailyMed Labels

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