FDA.reportPublic FDA data

IRBESARTAN

Product NDC
59746-449
11-digit product format
597460449
Labeler code
59746
Product ID
59746-449_45662cb2-60ef-45d5-80a2-fd60ee7250bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IRBESARTAN
Dosage form
TABLET
Route
ORAL
Labeler
Jubilant Cadista Pharmaceuticals Inc.
Application
ANDA203534
Marketing category
ANDA
Marketing start
2015-02-24
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59746-449-052023-02-24C16284748780-1f386c64a-1636-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997
59746-449-302023-02-24C16284748780-1f386c64a-1636-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997
59746-449-902023-02-24C16284748780-1f386c64a-1636-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997
59746-449-052023-01-30C16284748780-1f386c64a-1636-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997
59746-449-302023-01-30C16284748780-1f386c64a-1636-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997
59746-449-902023-01-30C16284748780-1f386c64a-1636-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59746-449-05IRBESARTAN500 in 1 BOTTLETABLET50016
59746-449-30IRBESARTAN30 in 1 BOTTLETABLET3016
59746-449-90IRBESARTAN90 in 1 BOTTLETABLET9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-449-30EA - Each59746-449af7cfdab-a158-4953-ba62-2f2444fa077012015-10-02
59746-449-90EA - Each59746-44900f70195-3439-4f2a-8b8b-8a65f0c93e3912015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
irbesartanACTIVE INGREDIENTJ0E2756Z7NIRBESARTAN (IRBESARTAN) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]7
irbesartanACTIVE MOIETYJ0E2756Z7NIRBESARTAN (IRBESARTAN) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]7
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UIRBESARTAN (IRBESARTAN) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]7
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48IRBESARTAN (IRBESARTAN) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]7
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XIRBESARTAN (IRBESARTAN) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]7
Magnesium StearateINACTIVE INGREDIENT70097M6I30IRBESARTAN (IRBESARTAN) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]7
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4IRBESARTAN (IRBESARTAN) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]7
starch, cornINACTIVE INGREDIENTO8232NY3SJIRBESARTAN (IRBESARTAN) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-449IRBESARTAN TABLET [JUBILANT CADISTA PHARMACUTICALS INC.]14Current NDC, Legacy NDC, 3 package rows20250424_068224c4-a34d-32d7-bb2a-7eed44ccf7d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200095irbesartan 150 MG Oral TabletPSN068224c4-a34d-32d7-bb2a-7eed44ccf7d316
200096irbesartan 300 MG Oral TabletPSN068224c4-a34d-32d7-bb2a-7eed44ccf7d316
200094irbesartan 75 MG Oral TabletPSN068224c4-a34d-32d7-bb2a-7eed44ccf7d316
200095irbesartan 150 MG Oral TabletSCD068224c4-a34d-32d7-bb2a-7eed44ccf7d316
200096irbesartan 300 MG Oral TabletSCD068224c4-a34d-32d7-bb2a-7eed44ccf7d316
200094irbesartan 75 MG Oral TabletSCD068224c4-a34d-32d7-bb2a-7eed44ccf7d316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-449-0559746044905500 TABLET in 1 BOTTLE (59746-449-05) 500 tablet2015-02-240000-00-00NoNoCurrent
59746-449-305974604493030 TABLET in 1 BOTTLE (59746-449-30) 30 tablet2015-02-240000-00-00NoNoCurrent
59746-449-905974604499090 TABLET in 1 BOTTLE (59746-449-90) 90 tablet2015-02-240000-00-00NoNoCurrent