FDA.reportPublic FDA data

Irbesartan

Product NDC
43547-376
11-digit product format
435470376
Labeler code
43547
Product ID
43547-376_9dd3ba36-25b6-45da-906f-316049b9f23b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare U.S., LLC
Application
ANDA203071
Marketing category
ANDA
Marketing start
2016-06-13
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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-376-03Irbesartan30 in 1 BOTTLETABLET307
43547-376-09Irbesartan90 in 1 BOTTLETABLET907
43547-376-50Irbesartan500 in 1 BOTTLETABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-376-03EA - Each43547-37650a0da29-6c77-4b60-bf37-bdb46b16474212016-10-06
43547-376-09EA - Each43547-3762cb277fb-cfcb-4975-bdeb-f07ac79d52c712016-10-06
43547-376-50EA - Each43547-376e0e287c9-b620-42f5-a663-fe63bad0aa5812016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-376IRBESARTAN TABLET [SOLCO HEALTHCARE U.S., LLC]5Current NDC, Legacy NDC, 3 package rows20220808_6916c617-92d2-44f5-b968-6267517a2ce6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200095irbesartan 150 MG Oral TabletPSN6916c617-92d2-44f5-b968-6267517a2ce67
200096irbesartan 300 MG Oral TabletPSN6916c617-92d2-44f5-b968-6267517a2ce67
200094irbesartan 75 MG Oral TabletPSN6916c617-92d2-44f5-b968-6267517a2ce67
200095irbesartan 150 MG Oral TabletSCD6916c617-92d2-44f5-b968-6267517a2ce67
200096irbesartan 300 MG Oral TabletSCD6916c617-92d2-44f5-b968-6267517a2ce67
200094irbesartan 75 MG Oral TabletSCD6916c617-92d2-44f5-b968-6267517a2ce67
200096irbesartan 300 MG Oral TabletPSN70a25c6d-23ce-488c-9ef8-62b3b99e50526
200096irbesartan 300 MG Oral TabletPSN9adacfa2-2814-4deb-9e34-c3b3c8dcd41a6
200096irbesartan 300 MG Oral TabletPSNefcd5f2e-1837-44ae-bc91-410c4d8b27c76
200096irbesartan 300 MG Oral TabletSCD70a25c6d-23ce-488c-9ef8-62b3b99e50526
200096irbesartan 300 MG Oral TabletSCD9adacfa2-2814-4deb-9e34-c3b3c8dcd41a6
200096irbesartan 300 MG Oral TabletSCDefcd5f2e-1837-44ae-bc91-410c4d8b27c76
200096irbesartan 300 MG Oral TabletPSN6babdb48-8384-49ce-a759-d380d79a40101
200096irbesartan 300 MG Oral TabletSCD6babdb48-8384-49ce-a759-d380d79a40101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-376-034354703760330 TABLET in 1 BOTTLE (43547-376-03) 30 tablet2016-06-130000-00-00NoNoCurrent
43547-376-094354703760990 TABLET in 1 BOTTLE (43547-376-09) 90 tablet2016-06-130000-00-00NoNoCurrent
43547-376-5043547037650500 TABLET in 1 BOTTLE (43547-376-50) 500 tablet2016-06-130000-00-00NoNoCurrent