Metronidazole
METRONIDAZOLE TABLETS, USP
Approved
Approval ID
31999703-3b31-4820-9319-1e5675c1ad82
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2009
Manufacturers
FDA
Apace Packaging
DUNS: 361961142
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Metronidazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15338-150
Application NumberNDA070033
Product Classification
M
Marketing Category
C73594
G
Generic Name
Metronidazole
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2010
FDA Product Classification
INGREDIENTS (4)
METRONIDAZOLEActive
Quantity: 500 mg in 1 1
Code: 140QMO216E
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT