Cinacalcet

Product NDC
63629-9607
11-digit product format
636299607
Labeler code
63629
Product ID
63629-9607_6c62ee47-9c52-451d-ac6c-e4742d0dad48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cinacalcet
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210570
Marketing category
ANDA
Marketing start
2019-05-18
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
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 formatDescriptionMarketing startSampleExclude flagStatus
63629-9607-16362996070130 TABLET, FILM COATED in 1 BOTTLE (63629-9607-1) 2022-12-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CinacalcetBryant Ranch Prepack2023-10-20HUMAN PRESCRIPTION DRUG LABEL102