Isoniazid
ISONIAZID TABLETS, USP
Approved
Approval ID
1247f0c8-25be-49b0-96e1-22b1cf50dc00
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 2, 2012
Manufacturers
FDA
VersaPharm Incorporated
DUNS: 956741896
Products 2
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 Code61748-013
Application NumberANDA087425
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isoniazid
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2010
FDA Product Classification
INGREDIENTS (6)
ISONIAZIDActive
Quantity: 300 mg in 1 1
Code: V83O1VOZ8L
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
Isoniazid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61748-016
Application NumberANDA080212
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isoniazid
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2010
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
ISONIAZIDActive
Quantity: 100 mg in 1 1
Code: V83O1VOZ8L
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT