Aminocaproic Acid
Aminocaproic Acid Tablets, USP
Approved
Approval ID
555a0910-dbeb-4643-8b3a-c9fe9b803b3c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 15, 2021
Manufacturers
FDA
Vitruvias Therapeutics
DUNS: 079200795
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Aminocaproic Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69680-116
Application NumberANDA209060
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aminocaproic Acid
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2021
FDA Product Classification
INGREDIENTS (5)
Aminocaproic AcidActive
Quantity: 1000 mg in 1 1
Code: U6F3787206
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Stearic AcidInactive
Code: 4ELV7Z65AP
Classification: IACT
Aminocaproic Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69680-115
Application NumberANDA209060
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aminocaproic Acid
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2021
FDA Product Classification
INGREDIENTS (5)
Aminocaproic AcidActive
Quantity: 500 mg in 1 1
Code: U6F3787206
Classification: ACTIB
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
Stearic AcidInactive
Code: 4ELV7Z65AP
Classification: IACT