FDA.reportPublic FDA data

Candesartan cilexetil

Product NDC
68151-3838
11-digit product format
681513838
Labeler code
68151
Product ID
68151-3838_076f9f04-922c-4c67-b65c-d8e866761de9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Candesartan cilexetil
Dosage form
TABLET
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA078702
Marketing category
ANDA
Marketing start
2013-05-21
Marketing end
0000-00-00
Substance
CANDESARTAN CILEXETIL
Active strength
16 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
03f056e9-4354-02cc-6010-79c6c9eaac0aProduct name620250521
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-3838-92020-01-31C16284748780-19d75b9d0-7897-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CANDESARTAN CILEXETIL TABLETS safely and effectively. See full prescribing information for CANDESARTAN CILEXETIL TABLETS. CANDESARTAN CILEXETIL Tablets, for oral use INITIAL U.S. APPROVAL: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-3838-9Candesartan cilexetil1 in 1 PACKAGETABLET13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CANDESARTAN CILEXETILACTIVE INGREDIENTR85M2X0D68CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]2
CANDESARTANACTIVE MOIETYS8Q36MD2XXCANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]2
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LCANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-3838CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160806_a67f4f53-76c7-4239-9dd6-fef8e8019e9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577776candesartan cilexetil 16 MG Oral TabletPSNa67f4f53-76c7-4239-9dd6-fef8e8019e9a3
577776candesartan cilexetil 16 MG Oral TabletSCDa67f4f53-76c7-4239-9dd6-fef8e8019e9a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-3838-9681513838091 in 1 PACKAGEHistorical