Isoniazid
Isoniazid Tablets USP
Approved
Approval ID
cb6f5638-2d3a-4334-b272-6b4772d32d03
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 23, 2020
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
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 Code71610-395
Application NumberANDA080937
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isoniazid
Product Specifications
Route of AdministrationORAL
Effective DateMarch 23, 2020
FDA Product Classification
INGREDIENTS (6)
ISONIAZIDActive
Quantity: 300 mg in 1 1
Code: V83O1VOZ8L
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT