Cinacalcet

Product NDC
42543-962
11-digit product format
425430962
Labeler code
42543
Product ID
42543-962_ebb3ed9d-c261-488e-97a1-940f63cd2a86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cinacalcet
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Strides Pharma Inc.
Application
ANDA209226
Marketing category
ANDA
Marketing start
2020-06-01
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42543-962-04EA - Each42543-9629ebe9360-b30b-4cee-9042-c9a59c13fcfa12020-08-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42543-962-044254309620430 TABLET, FILM COATED in 1 BOTTLE (42543-962-04) 2020-06-010000-00-00NoNoCurrent