CANDESARTAN CILEXETIL

Product NDC
46708-060
11-digit product format
467080060
Labeler code
46708
Product ID
46708-060_048b90e3-9511-49be-8513-ebd0bde1e03c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CANDESARTAN CILEXETIL
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA209119
Marketing category
ANDA
Marketing start
2017-06-21
Substance
CANDESARTAN CILEXETIL
Active strength
32 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 CILEXETIL32 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR85M2X0D68
Rxcui639537

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
46708-060-10CANDESARTAN CILEXETIL100 in 1 CARTONTABLET1003
46708-060-30CANDESARTAN CILEXETIL30 in 1 BOTTLETABLET303
46708-060-90CANDESARTAN CILEXETIL90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-060CANDESARTAN CILEXETIL TABLET [ALEMBIC PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 3 package rows20230115_d23fe59a-2ad6-4885-a0d8-2239048f05a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
639537candesartan cilexetil 32 MG Oral TabletPSNd23fe59a-2ad6-4885-a0d8-2239048f05a33
639537candesartan cilexetil 32 MG Oral TabletSCDd23fe59a-2ad6-4885-a0d8-2239048f05a33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-060-1046708006010100 TABLET in 1 CARTON (46708-060-10) 100 tablet2017-06-210000-00-00NoNoCurrent
46708-060-304670800603030 TABLET in 1 BOTTLE (46708-060-30) 30 tablet2017-06-210000-00-00NoNoCurrent
46708-060-904670800609090 TABLET in 1 BOTTLE (46708-060-90) 90 tablet2017-06-210000-00-00NoNoCurrent