CANDESARTAN CILEXETIL

Product NDC
62332-342
11-digit product format
623320342
Labeler code
62332
Product ID
62332-342_5a3c0018-b0e2-4fe7-bec7-c075f50833ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CANDESARTAN CILEXETIL
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-342-30CANDESARTAN CILEXETIL30 in 1 BOTTLETABLET306
62332-342-90CANDESARTAN CILEXETIL90 in 1 BOTTLETABLET906
62332-342-91CANDESARTAN CILEXETIL1000 in 1 BOTTLETABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-342-30EA - Each62332-3425d7ba0d4-d1e8-4160-b3ed-5b9d465f776812019-02-13
62332-342-90EA - Each62332-342ef25edf2-2d19-448c-a095-efe4e39b0bd912019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-342CANDESARTAN CILEXETIL TABLET [ALEMBIC PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 3 package rows20211002_8a515af5-bd53-43f1-b40a-aa0f332bc2ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577776candesartan cilexetil 16 MG Oral TabletPSN8a515af5-bd53-43f1-b40a-aa0f332bc2ab6
153822candesartan cilexetil 4 MG Oral TabletPSN8a515af5-bd53-43f1-b40a-aa0f332bc2ab6
153823candesartan cilexetil 8 MG Oral TabletPSN8a515af5-bd53-43f1-b40a-aa0f332bc2ab6
577776candesartan cilexetil 16 MG Oral TabletSCD8a515af5-bd53-43f1-b40a-aa0f332bc2ab6
153822candesartan cilexetil 4 MG Oral TabletSCD8a515af5-bd53-43f1-b40a-aa0f332bc2ab6
153823candesartan cilexetil 8 MG Oral TabletSCD8a515af5-bd53-43f1-b40a-aa0f332bc2ab6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-342-306233203423030 TABLET in 1 BOTTLE (62332-342-30) 30 tablet2018-12-050000-00-00NoNoCurrent
62332-342-906233203429090 TABLET in 1 BOTTLE (62332-342-90) 90 tablet2018-12-050000-00-00NoNoCurrent
62332-342-91623320342911000 TABLET in 1 BOTTLE (62332-342-91) 1000 tablet2018-12-050000-00-00NoNoCurrent