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
NDC Product Code69238-1637
Application NumberANDA212492
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 29, 2023
Generic NameAminocaproic acid
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