AMICAR
AMICAR
Approved
Approval ID
05b08095-2acc-47ef-a426-b68c7d95de95
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 6, 2018
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
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 Code68151-3023
Application NumberNDA015197
Product Classification
M
Marketing Category
C73594
G
Generic Name
Aminocaproic Acid
Product Specifications
Route of AdministrationORAL
Effective DateJune 11, 2015
FDA Product Classification
INGREDIENTS (5)
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
AMINOCAPROIC ACIDActive
Quantity: 500 mg in 1 1
Code: U6F3787206
Classification: ACTIB
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT