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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13925-531
Application NumberANDA213944
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aminocaproic Acid
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 11, 2020
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13925-530
Application NumberANDA213944
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aminocaproic Acid
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 11, 2020
FDA Product Classification
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