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.

NDC Product Code68151-3023

Application NumberNDA015197

Marketing CategoryC73594

Route of AdministrationORAL

Effective DateJune 11, 2015

Generic NameAminocaproic Acid

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