FDA.reportPublic FDA data

IRBESARTAN

Product NDC
62332-042
11-digit product format
623320042
Labeler code
62332
Product ID
62332-042_e21c14f4-6c8c-4676-b479-dff181ec3fa1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IRBESARTAN
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA091236
Marketing category
ANDA
Marketing start
2016-07-01
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
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
62332-042-30IRBESARTAN30 in 1 BOTTLETABLET3012
62332-042-31IRBESARTAN100 in 1 BOTTLETABLET10012
62332-042-71IRBESARTAN500 in 1 BOTTLETABLET50012
62332-042-90IRBESARTAN90 in 1 BOTTLETABLET9012
62332-042-91IRBESARTAN1000 in 1 BOTTLETABLET100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-042-30EA - Each62332-04274790c00-7674-471b-8f17-66e7515fc6dd12016-10-06
62332-042-71EA - Each62332-042dcfd2664-d757-4d9b-9a95-745757b4474012016-10-06
62332-042-90EA - Each62332-042af5f02ec-9483-4bae-9311-904881fa9b5512016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-042IRBESARTAN TABLET [ALEMBIC PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 5 package rows20211223_83f5d5c8-27c0-4208-a291-0c4aa55a1ff5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200095irbesartan 150 MG Oral TabletPSN83f5d5c8-27c0-4208-a291-0c4aa55a1ff512
200096irbesartan 300 MG Oral TabletPSN83f5d5c8-27c0-4208-a291-0c4aa55a1ff512
200094irbesartan 75 MG Oral TabletPSN83f5d5c8-27c0-4208-a291-0c4aa55a1ff512
200095irbesartan 150 MG Oral TabletSCD83f5d5c8-27c0-4208-a291-0c4aa55a1ff512
200096irbesartan 300 MG Oral TabletSCD83f5d5c8-27c0-4208-a291-0c4aa55a1ff512
200094irbesartan 75 MG Oral TabletSCD83f5d5c8-27c0-4208-a291-0c4aa55a1ff512
200095irbesartan 150 MG Oral TabletPSN01c9caf2-97f7-4d48-8599-51fc540470466
200095irbesartan 150 MG Oral TabletSCD01c9caf2-97f7-4d48-8599-51fc540470466

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-042-306233200423030 TABLET in 1 BOTTLE (62332-042-30) 30 tablet2016-07-010000-00-00NoNoCurrent
62332-042-3162332004231100 TABLET in 1 BOTTLE (62332-042-31) 100 tablet2016-07-010000-00-00NoNoCurrent
62332-042-7162332004271500 TABLET in 1 BOTTLE (62332-042-71) 500 tablet2016-07-010000-00-00NoNoCurrent
62332-042-906233200429090 TABLET in 1 BOTTLE (62332-042-90) 90 tablet2016-07-010000-00-00NoNoCurrent
62332-042-91623320042911000 TABLET in 1 BOTTLE (62332-042-91) 1000 tablet2016-07-010000-00-00NoNoCurrent