Candesartan cilexetil

Product NDC
49884-661
11-digit product format
498840661
Labeler code
49884
Product ID
49884-661_17510ed6-8915-41ab-9f20-8572368f2235
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Candesartan cilexetil
Dosage form
TABLET
Route
ORAL
Labeler
Par Pharmaceutical Inc.
Application
NDA020838
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-05-21
Marketing end
0000-00-00
Substance
CANDESARTAN CILEXETIL
Active strength
32 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-661-09EA - Each49884-66162b3a739-ebb3-48b5-9c7a-89a89eaef3c612013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CANDESARTAN CILEXETILACTIVE INGREDIENTR85M2X0D68CANDESARTAN CILEXETIL TABLET [PAR PHARMACEUTICAL INC.]4
CANDESARTANACTIVE MOIETYS8Q36MD2XXCANDESARTAN CILEXETIL TABLET [PAR PHARMACEUTICAL INC.]4
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LCANDESARTAN CILEXETIL TABLET [PAR PHARMACEUTICAL INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CANDESARTAN CILEXETIL TABLET [PAR PHARMACEUTICAL INC.]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCANDESARTAN CILEXETIL TABLET [PAR PHARMACEUTICAL INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCANDESARTAN CILEXETIL TABLET [PAR PHARMACEUTICAL INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CANDESARTAN CILEXETIL TABLET [PAR PHARMACEUTICAL INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACANDESARTAN CILEXETIL TABLET [PAR PHARMACEUTICAL INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCANDESARTAN CILEXETIL TABLET [PAR PHARMACEUTICAL INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-661CANDESARTAN CILEXETIL TABLET [PAR PHARMACEUTICAL INC.]12Legacy NDC20240406_1c90aa68-cc12-41ef-aebc-2616ae45683a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-661-094988406610990 TABLET in 1 BOTTLE (49884-661-09) 90 tablet2013-05-210000-00-00NoNoCurrent