Isoniazid
ISONIAZID TABLETS, USP
Approved
Approval ID
e43d77c2-f7e8-4d84-9425-37adb38410f0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 12, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Isoniazid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-145
Application NumberANDA087425
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isoniazid
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2010
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
ISONIAZIDActive
Quantity: 300 mg in 1 1
Code: V83O1VOZ8L
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT