FDA.reportPublic FDA data

candesartan cilexetil

Product NDC
0378-3231
11-digit product format
003783231
Labeler code
0378
Product ID
0378-3231_62815e9d-598e-4b5f-b33b-3a9659eec024
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
candesartan cilexetil
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA078702
Marketing category
ANDA
Marketing start
2020-01-06
Substance
CANDESARTAN CILEXETIL
Active strength
16 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 CILEXETIL16 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
0378-3231-77candesartan cilexetil90 in 1 BOTTLE, PLASTICTABLET904
0378-3231-93candesartan cilexetil30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-3231-77EA - Each0378-323121242642-be6a-49dd-a11e-967f5ff7a7f512020-02-13
0378-3231-93EA - Each0378-32319f3eac6a-17f1-4f6e-bf7f-e0f8860c419212020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-3231CANDESARTAN CILEXETIL TABLET [MYLAN PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20240126_904b357e-97bf-475e-90a5-f0449f2a428e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577776candesartan cilexetil 16 MG Oral TabletPSN904b357e-97bf-475e-90a5-f0449f2a428e4
639537candesartan cilexetil 32 MG Oral TabletPSN904b357e-97bf-475e-90a5-f0449f2a428e4
153822candesartan cilexetil 4 MG Oral TabletPSN904b357e-97bf-475e-90a5-f0449f2a428e4
153823candesartan cilexetil 8 MG Oral TabletPSN904b357e-97bf-475e-90a5-f0449f2a428e4
577776candesartan cilexetil 16 MG Oral TabletSCD904b357e-97bf-475e-90a5-f0449f2a428e4
639537candesartan cilexetil 32 MG Oral TabletSCD904b357e-97bf-475e-90a5-f0449f2a428e4
153822candesartan cilexetil 4 MG Oral TabletSCD904b357e-97bf-475e-90a5-f0449f2a428e4
153823candesartan cilexetil 8 MG Oral TabletSCD904b357e-97bf-475e-90a5-f0449f2a428e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-3231-770037832317790 TABLET in 1 BOTTLE, PLASTIC (0378-3231-77) 90 tablet2020-01-060000-00-00NoNoCurrent
0378-3231-930037832319330 TABLET in 1 BOTTLE, PLASTIC (0378-3231-93) 30 tablet2020-01-060000-00-00NoNoCurrent