Aminocaproic acid
Aminocaproic Acid Oral Solution, USP Rx only
Approved
Approval ID
65efb08a-c1ae-4bb7-a8a2-b7ae26485567
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 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 Code69238-1596
Application NumberANDA212780
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aminocaproic acid
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2023
FDA Product Classification
INGREDIENTS (11)
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
AMINOCAPROIC ACIDActive
Quantity: 0.25 g in 1 mL
Code: U6F3787206
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
RASPBERRYInactive
Code: 4N14V5R27W
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT