Aminocaproic acid
Aminocaproic Acid Tablets, USP (500 mg) Rx only
Approved
Approval ID
4a22e559-2dac-42d7-af8d-eb0ebbc2f76d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2023
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
Products 1
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 Code69238-1637
Application NumberANDA212492
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aminocaproic acid
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2023
FDA Product Classification
INGREDIENTS (5)
AMINOCAPROIC ACIDActive
Quantity: 500 mg in 1 1
Code: U6F3787206
Classification: ACTIB
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT