CANDESARTAN CILEXETIL

Product NDC
63629-9842
11-digit product format
636299842
Labeler code
63629
Product ID
63629-9842_fa56d3f2-c4d2-4bc1-998d-82d0e6a56e98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CANDESARTAN CILEXETIL
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210302
Marketing category
ANDA
Marketing start
2018-12-05
Substance
CANDESARTAN CILEXETIL
Active strength
16 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
R85M2X0D68CANDESARTAN CILEXETIL145040-37-5CANDESARTAN CILEXETIL

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-9842-16362998420130 TABLET in 1 BOTTLE (63629-9842-1) 30 tablet2023-09-25NoNoHistorical
63629-9842-26362998420290 TABLET in 1 BOTTLE (63629-9842-2) 90 tablet2023-09-25NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CANDESARTAN CILEXETILBryant Ranch Prepack2023-09-25HUMAN PRESCRIPTION DRUG LABEL100