Metronidazole
METRONIDAZOLE TABLETS USP
Approved
Approval ID
3193a61d-acc4-445a-8bb9-328568d43937
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Metronidazole
PRODUCT DETAILS
NDC Product Code16590-385
Application NumberANDA070027
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 4, 2012
Generic NameMetronidazole
INGREDIENTS (5)
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
METRONIDAZOLEActive
Quantity: 250 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
Metronidazole
PRODUCT DETAILS
NDC Product Code16590-152
Application NumberANDA070033
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 4, 2012
Generic NameMetronidazole
INGREDIENTS (5)
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
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT