FDA.reportPublic FDA data

Irbesartan

Product NDC
70518-2246
11-digit product format
705182246
Labeler code
70518
Product ID
70518-2246_4dd961b2-c2cd-4347-e063-6394a90ae712
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202910
Marketing category
ANDA
Marketing start
2019-08-01
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
Rxcui200096

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
70518-2246-02023-03-08C16284748780-1f386c649-e923-0266-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
70518-2246-02023-03-08C16284748780-1f386c649-e923-0266-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
70518-2246-02023-01-30C16284748780-1f386c649-e923-0266-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
70518-2246-02023-01-30C16284748780-1f386c649-e923-0266-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
70518-2246-0Irbesartan90 in 1 BOTTLE, PLASTICTABLET909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2246IRBESARTAN TABLET [REMEDYREPACK INC.]6Current NDC, Legacy NDC, 1 package rows20250309_bb58acb0-2dc0-45ee-86bb-b405b1b75cff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200096irbesartan 300 MG Oral TabletPSNbb58acb0-2dc0-45ee-86bb-b405b1b75cff9
200096irbesartan 300 MG Oral TabletSCDbb58acb0-2dc0-45ee-86bb-b405b1b75cff9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2246-07051822460090 TABLET in 1 BOTTLE, PLASTIC (70518-2246-0) 90 tablet2019-08-010000-00-00NoNoCurrent