Aminocaproic Acid
Aminocaproic Acid Tablets, USP
Approved
Approval ID
d947ab60-353e-48e0-848b-015ac7a7f8d4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 11, 2020
Manufacturers
FDA
Seton Pharmaceuticals, LLC
DUNS: 828898002
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
NDC Product Code13925-531
Application NumberANDA213944
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 11, 2020
Generic NameAminocaproic Acid
INGREDIENTS (6)
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
AMINOCAPROIC ACIDActive
Quantity: 1000 mg in 1 1
Code: U6F3787206
Classification: ACTIB
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
Aminocaproic Acid
PRODUCT DETAILS
NDC Product Code13925-530
Application NumberANDA213944
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 11, 2020
Generic NameAminocaproic Acid
INGREDIENTS (6)
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
AMINOCAPROIC ACIDActive
Quantity: 500 mg in 1 1
Code: U6F3787206
Classification: ACTIB