FDA.reportPublic FDA data

Candesartan cilexetil

Product NDC
62559-689
11-digit product format
625590689
Labeler code
62559
Product ID
62559-689_9cfa9177-a7c4-416c-9328-dfdb4f27bfde
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Candesartan cilexetil
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
NDA020838
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-03-15
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
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
62559-689-98Candesartan cilexetil25000 in 1 BOXTABLET250002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-689-98EA - Each62559-689f55a2c4b-74d9-48cf-b540-33caec4db6ab12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-689CANDESARTAN CILEXETIL TABLET [ANI PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20240316_4621249c-1f44-4d95-8513-a1a2b1859e41.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577776candesartan cilexetil 16 MG Oral TabletPSN15601654-76da-04cf-e063-6394a90a2cb52
577776candesartan cilexetil 16 MG Oral TabletPSN4621249c-1f44-4d95-8513-a1a2b1859e412
639537candesartan cilexetil 32 MG Oral TabletPSN15601654-76da-04cf-e063-6394a90a2cb52
639537candesartan cilexetil 32 MG Oral TabletPSN4621249c-1f44-4d95-8513-a1a2b1859e412
153822candesartan cilexetil 4 MG Oral TabletPSN15601654-76da-04cf-e063-6394a90a2cb52
153822candesartan cilexetil 4 MG Oral TabletPSN4621249c-1f44-4d95-8513-a1a2b1859e412
153823candesartan cilexetil 8 MG Oral TabletPSN15601654-76da-04cf-e063-6394a90a2cb52
153823candesartan cilexetil 8 MG Oral TabletPSN4621249c-1f44-4d95-8513-a1a2b1859e412
577776candesartan cilexetil 16 MG Oral TabletSCD15601654-76da-04cf-e063-6394a90a2cb52
577776candesartan cilexetil 16 MG Oral TabletSCD4621249c-1f44-4d95-8513-a1a2b1859e412
639537candesartan cilexetil 32 MG Oral TabletSCD15601654-76da-04cf-e063-6394a90a2cb52
639537candesartan cilexetil 32 MG Oral TabletSCD4621249c-1f44-4d95-8513-a1a2b1859e412
153822candesartan cilexetil 4 MG Oral TabletSCD15601654-76da-04cf-e063-6394a90a2cb52
153822candesartan cilexetil 4 MG Oral TabletSCD4621249c-1f44-4d95-8513-a1a2b1859e412
153823candesartan cilexetil 8 MG Oral TabletSCD15601654-76da-04cf-e063-6394a90a2cb52
153823candesartan cilexetil 8 MG Oral TabletSCD4621249c-1f44-4d95-8513-a1a2b1859e412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62559-689-986255906899825000 TABLET in 1 BOX (62559-689-98) 25000 tablet2024-03-15NoNoHistorical