FDA.reportPublic FDA data

Irbesartan

Product NDC
71205-082
11-digit product format
712050082
Labeler code
71205
Product ID
71205-082_b40bb16b-4019-4002-8d5e-64c5f887f10b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203071
Marketing category
ANDA
Marketing start
2016-06-13
Substance
IRBESARTAN
Active strength
150 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
IRBESARTAN150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ0E2756Z7N
Rxcui200095

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
71205-082-30Irbesartan30 in 1 BOTTLETABLET302
71205-082-60Irbesartan60 in 1 BOTTLETABLET602
71205-082-90Irbesartan90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-082-30EA - Each71205-08261fdb22c-9adb-49bd-8a99-aafb53b313bb12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-082IRBESARTAN TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20191029_b587d89b-8ff9-4180-b31a-bbff5d365a1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200095irbesartan 150 MG Oral TabletPSNb587d89b-8ff9-4180-b31a-bbff5d365a1d2
200095irbesartan 150 MG Oral TabletSCDb587d89b-8ff9-4180-b31a-bbff5d365a1d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-082-307120500823030 TABLET in 1 BOTTLE (71205-082-30) 30 tablet2018-08-010000-00-00NoNoCurrent
71205-082-607120500826060 TABLET in 1 BOTTLE (71205-082-60) 60 tablet2018-08-010000-00-00NoNoCurrent
71205-082-907120500829090 TABLET in 1 BOTTLE (71205-082-90) 90 tablet2018-08-010000-00-00NoNoCurrent