FDA.reportPublic FDA data

Irbesartan

Product NDC
43547-375
11-digit product format
435470375
Labeler code
43547
Product ID
43547-375_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
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
43547-375-03Irbesartan30 in 1 BOTTLETABLET307
43547-375-09Irbesartan90 in 1 BOTTLETABLET907
43547-375-50Irbesartan500 in 1 BOTTLETABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-375-03EA - Each43547-375fa90994e-ad22-4421-b22a-c5cbc268a41512016-10-06
43547-375-09EA - Each43547-3758c21f7eb-6e45-471f-a95e-824c728f2b0212016-10-06
43547-375-50EA - Each43547-3758452fd68-12d4-437d-9368-d1f0e88c00fe12016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-375IRBESARTAN 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 TabletPSN1ab1ff46-d0b1-4762-9ebf-3e07dde8b048101
200095irbesartan 150 MG Oral TabletPSNecc490ea-a68e-4261-8be2-5020ac5ab803101
200095irbesartan 150 MG Oral TabletSCD1ab1ff46-d0b1-4762-9ebf-3e07dde8b048101
200095irbesartan 150 MG Oral TabletSCDecc490ea-a68e-4261-8be2-5020ac5ab803101
200095irbesartan 150 MG Oral TabletPSN029a90b6-0722-49be-8400-3ec29526aafd10
200095irbesartan 150 MG Oral TabletSCD029a90b6-0722-49be-8400-3ec29526aafd10
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
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
43547-375-034354703750330 TABLET in 1 BOTTLE (43547-375-03) 30 tablet2016-06-130000-00-00NoNoCurrent
43547-375-094354703750990 TABLET in 1 BOTTLE (43547-375-09) 90 tablet2016-06-130000-00-00NoNoCurrent
43547-375-5043547037550500 TABLET in 1 BOTTLE (43547-375-50) 500 tablet2016-06-130000-00-00NoNoCurrent