Isoniazid
ISONIAZID TABLETS, USP 100 mg and 300 mg
Approved
Approval ID
63dd70bb-e79b-4fa4-93f1-314440354813
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 4, 2013
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-2304
Application NumberANDA080936
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isoniazid
Product Specifications
Route of AdministrationORAL
Effective DateMarch 4, 2013
FDA Product Classification
INGREDIENTS (6)
ISONIAZIDActive
Quantity: 100 mg in 1 1
Code: V83O1VOZ8L
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Isoniazid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-2416
Application NumberANDA080937
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isoniazid
Product Specifications
Route of AdministrationORAL
Effective DateMarch 4, 2013
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ISONIAZIDActive
Quantity: 300 mg in 1 1
Code: V83O1VOZ8L
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT