FDA.reportPublic FDA data

Irbesartan

Product NDC
71205-379
11-digit product format
712050379
Labeler code
71205
Product ID
71205-379_003c2047-0d19-4a1c-b162-31ef2c319faf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202254
Marketing category
ANDA
Marketing start
2012-09-27
Substance
IRBESARTAN
Active strength
75 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
IRBESARTAN75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ0E2756Z7N
Rxcui200094

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
71205-379-30Irbesartan30 in 1 BOTTLETABLET302
71205-379-60Irbesartan60 in 1 BOTTLETABLET602
71205-379-90Irbesartan90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-379-30EA - Each71205-37962f0879e-8cbc-4c01-9163-463b9cc0708e12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-379IRBESARTAN TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220715_f0ec2ccc-7d79-4cde-a13e-08faeea4e934.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200094irbesartan 75 MG Oral TabletPSNf0ec2ccc-7d79-4cde-a13e-08faeea4e9342
200094irbesartan 75 MG Oral TabletSCDf0ec2ccc-7d79-4cde-a13e-08faeea4e9342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-379-307120503793030 TABLET in 1 BOTTLE (71205-379-30) 30 tablet2020-01-060000-00-00NoNoCurrent
71205-379-607120503796060 TABLET in 1 BOTTLE (71205-379-60) 60 tablet2020-01-060000-00-00NoNoCurrent
71205-379-907120503799090 TABLET in 1 BOTTLE (71205-379-90) 90 tablet2020-01-060000-00-00NoNoCurrent