FDA.reportPublic FDA data

Candesartan

Product NDC
33342-115
11-digit product format
333420115
Labeler code
33342
Product ID
33342-115_4079c843-42ee-4f7a-a4a0-9498ba6cf12d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Candesartan
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA203813
Marketing category
ANDA
Marketing start
2016-12-06
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
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, 639537

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
33342-115-07Candesartan30 in 1 CONTAINERTABLET306
33342-115-10Candesartan90 in 1 CONTAINERTABLET906
33342-115-12Candesartan10 in 1 BLISTER PACKTABLET106
33342-115-12Candesartan10 in 1 CARTONTABLET106
33342-115-51Candesartan300 in 1 CONTAINERTABLET3006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-115-07EA - Each33342-115fe5b5511-51bf-4b36-a7fd-9e5329b8e7d812017-04-05
33342-115-10EA - Each33342-11551b884d9-9be3-4ac9-8065-14747d2d134e12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-115CANDESARTAN TABLET [MACLEODS PHARMACEUTICALS LIMITED]6Current NDC, Legacy NDC, 5 package rows20221231_8ceb5658-b03c-475d-9ef0-2cd0645191d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577776candesartan cilexetil 16 MG Oral TabletPSN8ceb5658-b03c-475d-9ef0-2cd0645191d36
639537candesartan cilexetil 32 MG Oral TabletPSN8ceb5658-b03c-475d-9ef0-2cd0645191d36
153822candesartan cilexetil 4 MG Oral TabletPSN8ceb5658-b03c-475d-9ef0-2cd0645191d36
153823candesartan cilexetil 8 MG Oral TabletPSN8ceb5658-b03c-475d-9ef0-2cd0645191d36
577776candesartan cilexetil 16 MG Oral TabletSCD8ceb5658-b03c-475d-9ef0-2cd0645191d36
639537candesartan cilexetil 32 MG Oral TabletSCD8ceb5658-b03c-475d-9ef0-2cd0645191d36
153822candesartan cilexetil 4 MG Oral TabletSCD8ceb5658-b03c-475d-9ef0-2cd0645191d36
153823candesartan cilexetil 8 MG Oral TabletSCD8ceb5658-b03c-475d-9ef0-2cd0645191d36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-115-073334201150730 TABLET in 1 CONTAINER (33342-115-07) 30 tablet2016-12-060000-00-00NoNoCurrent
33342-115-103334201151090 TABLET in 1 CONTAINER (33342-115-10) 90 tablet2016-12-060000-00-00NoNoCurrent
33342-115-123334201151210 BLISTER PACK in 1 CARTON (33342-115-12) / 10 TABLET in 1 BLISTER PACK10 blister pack2016-12-060000-00-00NoNoCurrent
33342-115-5133342011551300 TABLET in 1 CONTAINER (33342-115-51) 300 tablet2016-12-060000-00-00NoNoCurrent