FDA.reportPublic FDA data

ATACAND

Product NDC
62559-642
11-digit product format
625590642
Labeler code
62559
Product ID
62559-642_6ae461eb-f06a-4bf1-b6da-73d66b99b33c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Candesartan Cilexetil
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
NDA020838
Marketing category
NDA
Marketing start
2018-10-01
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
ATACAND
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, 577785, 577787, 639537, 639539, 639543

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
62559-642-30ATACAND30 in 1 BOTTLETABLET305
62559-642-90ATACAND90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-642-30EA - Each62559-64283d371f0-15b6-4705-8ee9-d2e3667db44212018-11-06
62559-642-90EA - Each62559-64270a0cf15-00f3-4661-8156-38047d235fe812018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-642ATACAND (CANDESARTAN CILEXETIL) TABLET [ANI PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 2 package rows20200627_94a59260-d2b6-464a-b5b9-bbc599e57e10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
639539Atacand 16 MG Oral TabletPSN94a59260-d2b6-464a-b5b9-bbc599e57e105
639543Atacand 32 MG Oral TabletPSN94a59260-d2b6-464a-b5b9-bbc599e57e105
577785Atacand 4 MG Oral TabletPSN94a59260-d2b6-464a-b5b9-bbc599e57e105
577787Atacand 8 MG Oral TabletPSN94a59260-d2b6-464a-b5b9-bbc599e57e105
577776candesartan cilexetil 16 MG Oral TabletPSN94a59260-d2b6-464a-b5b9-bbc599e57e105
639537candesartan cilexetil 32 MG Oral TabletPSN94a59260-d2b6-464a-b5b9-bbc599e57e105
153822candesartan cilexetil 4 MG Oral TabletPSN94a59260-d2b6-464a-b5b9-bbc599e57e105
153823candesartan cilexetil 8 MG Oral TabletPSN94a59260-d2b6-464a-b5b9-bbc599e57e105
639539candesartan cilexetil 16 MG Oral Tablet [Atacand]SBD94a59260-d2b6-464a-b5b9-bbc599e57e105
639543candesartan cilexetil 32 MG Oral Tablet [Atacand]SBD94a59260-d2b6-464a-b5b9-bbc599e57e105
577785candesartan cilexetil 4 MG Oral Tablet [Atacand]SBD94a59260-d2b6-464a-b5b9-bbc599e57e105
577787candesartan cilexetil 8 MG Oral Tablet [Atacand]SBD94a59260-d2b6-464a-b5b9-bbc599e57e105
577776candesartan cilexetil 16 MG Oral TabletSCD94a59260-d2b6-464a-b5b9-bbc599e57e105
639537candesartan cilexetil 32 MG Oral TabletSCD94a59260-d2b6-464a-b5b9-bbc599e57e105
153822candesartan cilexetil 4 MG Oral TabletSCD94a59260-d2b6-464a-b5b9-bbc599e57e105
153823candesartan cilexetil 8 MG Oral TabletSCD94a59260-d2b6-464a-b5b9-bbc599e57e105
639539Atacand 16 MG Oral TabletSY94a59260-d2b6-464a-b5b9-bbc599e57e105
639543Atacand 32 MG Oral TabletSY94a59260-d2b6-464a-b5b9-bbc599e57e105
577785Atacand 4 MG Oral TabletSY94a59260-d2b6-464a-b5b9-bbc599e57e105
577787Atacand 8 MG Oral TabletSY94a59260-d2b6-464a-b5b9-bbc599e57e105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-642-306255906423030 TABLET in 1 BOTTLE (62559-642-30) 30 tablet2018-10-010000-00-00NoNoCurrent
62559-642-906255906429090 TABLET in 1 BOTTLE (62559-642-90) 90 tablet2018-10-010000-00-00NoNoCurrent