Isoniazid
ISONIAZID TABLETS, USP 100 mg and 300 mg
Approved
Approval ID
2b87aa05-8028-1b46-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 11, 2016
Manufacturers
FDA
Department of State Health Services, Pharmacy Branch
DUNS: 781992540
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 Code55695-027
Application NumberANDA080936
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isoniazid
Product Specifications
Route of AdministrationORAL
Effective DateMarch 11, 2016
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ISONIAZIDActive
Quantity: 100 mg in 1 1
Code: V83O1VOZ8L
Classification: ACTIB
Isoniazid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55695-033
Application NumberANDA080937
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isoniazid
Product Specifications
Route of AdministrationORAL
Effective DateMarch 11, 2016
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ISONIAZIDActive
Quantity: 300 mg in 1 1
Code: V83O1VOZ8L
Classification: ACTIB