FDA.reportPublic FDA data

CANDESARTAN CILEXETIL

Product NDC
46708-342
11-digit product format
467080342
Labeler code
46708
Product ID
46708-342_aaa63206-6c7d-4996-8991-91bfdb69b821
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CANDESARTAN CILEXETIL
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA210302
Marketing category
ANDA
Marketing start
2018-12-05
Substance
CANDESARTAN CILEXETIL
Active strength
8 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

Additional Listing Data#

Finished product
Yes
Brand name base
CANDESARTAN CILEXETIL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CANDESARTAN CILEXETIL8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR85M2X0D68
Rxcui153822, 153823, 577776

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
46708-342-302023-01-31C16284748780-1f386c649-b137-0266-e053-dadaa90a7c1aThese 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
46708-342-902023-01-31C16284748780-1f386c649-b137-0266-e053-dadaa90a7c1aThese 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
46708-342-912023-01-31C16284748780-1f386c649-b137-0266-e053-dadaa90a7c1aThese 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
46708-342-302023-01-30C16284748780-1f386c649-b137-0266-e053-dadaa90a7c1aThese 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
46708-342-902023-01-30C16284748780-1f386c649-b137-0266-e053-dadaa90a7c1aThese 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
46708-342-912023-01-30C16284748780-1f386c649-b137-0266-e053-dadaa90a7c1aThese 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
46708-342-30CANDESARTAN CILEXETIL30 in 1 BOTTLETABLET304
46708-342-90CANDESARTAN CILEXETIL90 in 1 BOTTLETABLET904
46708-342-91CANDESARTAN CILEXETIL1000 in 1 BOTTLETABLET10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-342CANDESARTAN CILEXETIL TABLET [ALEMBIC PHARMACEUTICALS LIMITED]4Current NDC, Legacy NDC, 3 package rows20230202_d5b43fa0-6678-4219-99f1-10d273d49baf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577776candesartan cilexetil 16 MG Oral TabletPSNd5b43fa0-6678-4219-99f1-10d273d49baf4
153822candesartan cilexetil 4 MG Oral TabletPSNd5b43fa0-6678-4219-99f1-10d273d49baf4
153823candesartan cilexetil 8 MG Oral TabletPSNd5b43fa0-6678-4219-99f1-10d273d49baf4
577776candesartan cilexetil 16 MG Oral TabletSCDd5b43fa0-6678-4219-99f1-10d273d49baf4
153822candesartan cilexetil 4 MG Oral TabletSCDd5b43fa0-6678-4219-99f1-10d273d49baf4
153823candesartan cilexetil 8 MG Oral TabletSCDd5b43fa0-6678-4219-99f1-10d273d49baf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-342-304670803423030 TABLET in 1 BOTTLE (46708-342-30) 30 tablet2018-12-050000-00-00NoNoCurrent
46708-342-904670803429090 TABLET in 1 BOTTLE (46708-342-90) 90 tablet2018-12-050000-00-00NoNoCurrent
46708-342-91467080342911000 TABLET in 1 BOTTLE (46708-342-91) 1000 tablet2018-12-050000-00-00NoNoCurrent