FDA.reportPublic FDA data

Irbesartan

Product NDC
65862-639
11-digit product format
658620639
Labeler code
65862
Product ID
65862-639_9e17df53-3757-4012-a76f-d1aa0053fda0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA203081
Marketing category
ANDA
Marketing start
2012-09-27
Substance
IRBESARTAN
Active strength
300 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
Irbesartan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IRBESARTAN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ0E2756Z7N
Rxcui200094, 200095, 200096

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
34942a29-de4f-d63c-7755-ba18fe1411a0Product name620180619
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-639-05Irbesartan500 in 1 BOTTLETABLET50011
65862-639-10Irbesartan10 in 1 BLISTER PACKTABLET1011
65862-639-30Irbesartan30 in 1 BOTTLETABLET3011
65862-639-78Irbesartan10 in 1 CARTONTABLET1011
65862-639-90Irbesartan90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-639-05EA - Each65862-639145c0a48-4eaf-4c3c-a911-43edee3dd22c12013-02-13
65862-639-30EA - Each65862-639c4af390a-9bfb-4105-b08d-c102f20db03912013-02-13
65862-639-90EA - Each65862-639cfda0686-9e0a-4063-a907-30fbc59849a012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IRBESARTANACTIVE INGREDIENTJ0E2756Z7NIRBESARTAN TABLET [AUROBINDO PHARMA LIMITED]2
IRBESARTANACTIVE MOIETYJ0E2756Z7NIRBESARTAN TABLET [AUROBINDO PHARMA LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIRBESARTAN TABLET [AUROBINDO PHARMA LIMITED]2
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPIRBESARTAN TABLET [AUROBINDO PHARMA LIMITED]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4IRBESARTAN TABLET [AUROBINDO PHARMA LIMITED]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIRBESARTAN TABLET [AUROBINDO PHARMA LIMITED]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IRBESARTAN TABLET [AUROBINDO PHARMA LIMITED]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IRBESARTAN TABLET [AUROBINDO PHARMA LIMITED]2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIIRBESARTAN TABLET [AUROBINDO PHARMA LIMITED]2
TALCINACTIVE INGREDIENT7SEV7J4R1UIRBESARTAN TABLET [AUROBINDO PHARMA LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-639IRBESARTAN TABLET [AUROBINDO PHARMA LIMITED]9Current NDC, Legacy NDC, 5 package rows20240516_2113a901-2612-4557-b86d-3afc006fb8bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200095irbesartan 150 MG Oral TabletPSN2113a901-2612-4557-b86d-3afc006fb8bb11
200096irbesartan 300 MG Oral TabletPSN2113a901-2612-4557-b86d-3afc006fb8bb11
200094irbesartan 75 MG Oral TabletPSN2113a901-2612-4557-b86d-3afc006fb8bb11
200095irbesartan 150 MG Oral TabletSCD2113a901-2612-4557-b86d-3afc006fb8bb11
200096irbesartan 300 MG Oral TabletSCD2113a901-2612-4557-b86d-3afc006fb8bb11
200094irbesartan 75 MG Oral TabletSCD2113a901-2612-4557-b86d-3afc006fb8bb11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-639-0565862063905500 TABLET in 1 BOTTLE (65862-639-05) 500 tablet2012-09-270000-00-00NoNoCurrent
65862-639-106586206391010 in 1 BLISTER PACKHistorical
65862-639-306586206393030 TABLET in 1 BOTTLE (65862-639-30) 30 tablet2012-09-270000-00-00NoNoCurrent
65862-639-786586206397810 BLISTER PACK in 1 CARTON (65862-639-78) / 10 TABLET in 1 BLISTER PACK (65862-639-10) 10 blister pack2014-09-220000-00-00NoNoCurrent
65862-639-906586206399090 TABLET in 1 BOTTLE (65862-639-90) 90 tablet2012-09-270000-00-00NoNoCurrent