AVAPRO
AVAPRO (irbesartan) Tablets
Approved
Approval ID
4536ad0b-42f4-4bd1-83d4-467762291664
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
IRBESARTAN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4414
Application NumberNDA020757
Product Classification
M
Marketing Category
C73594
G
Generic Name
IRBESARTAN
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2011
FDA Product Classification
INGREDIENTS (8)
irbesartanActive
Quantity: 300 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
poloxamer 188Inactive
Code: LQA7B6G8JG
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
IRBESARTAN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4199
Application NumberNDA020757
Product Classification
M
Marketing Category
C73594
G
Generic Name
IRBESARTAN
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2011
FDA Product Classification
INGREDIENTS (8)
irbesartanActive
Quantity: 150 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
poloxamer 188Inactive
Code: LQA7B6G8JG
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT