Candesartan cilexetil

Product NDC
70771-1205
11-digit product format
707711205
Labeler code
70771
Product ID
70771-1205_c7bdc8a6-d668-43d8-b824-8d83bbe6664d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Candesartan cilexetil
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA091390
Marketing category
ANDA
Marketing start
2018-02-22
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Candesartan cilexetil
Listing expiration
2027-12-31

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
70771-1205-3Candesartan cilexetil30 in 1 BOTTLETABLET305
70771-1205-9Candesartan cilexetil90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1205CANDESARTAN CILEXETIL TABLET [ZYDUS LIFESCIENCES LIMITED]4Current NDC, Legacy NDC, 2 package rows20221015_26df3269-3682-4ce0-be81-8c029254b5a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577776candesartan cilexetil 16 MG Oral TabletPSN26df3269-3682-4ce0-be81-8c029254b5a85
639537candesartan cilexetil 32 MG Oral TabletPSN26df3269-3682-4ce0-be81-8c029254b5a85
153822candesartan cilexetil 4 MG Oral TabletPSN26df3269-3682-4ce0-be81-8c029254b5a85
153823candesartan cilexetil 8 MG Oral TabletPSN26df3269-3682-4ce0-be81-8c029254b5a85
577776candesartan cilexetil 16 MG Oral TabletSCD26df3269-3682-4ce0-be81-8c029254b5a85
639537candesartan cilexetil 32 MG Oral TabletSCD26df3269-3682-4ce0-be81-8c029254b5a85
153822candesartan cilexetil 4 MG Oral TabletSCD26df3269-3682-4ce0-be81-8c029254b5a85
153823candesartan cilexetil 8 MG Oral TabletSCD26df3269-3682-4ce0-be81-8c029254b5a85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1205-37077112050330 TABLET in 1 BOTTLE (70771-1205-3) 30 tablet2018-02-220000-00-00NoNoCurrent
70771-1205-570771120505500 TABLET in 1 BOTTLE (70771-1205-5) 500 tablet2018-02-220000-00-00NoNoCurrent
70771-1205-97077112050990 TABLET in 1 BOTTLE (70771-1205-9) 90 tablet2018-02-220000-00-00NoNoCurrent