metronidazole
Metronidazole Tablets, USPRx only
Approved
Approval ID
4920fcf7-5ceb-46e9-82e0-dc508900bb91
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2022
Manufacturers
FDA
AMICI PHARMACEUTICALS LLC
DUNS: 079536824
Products 2
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 Code69292-206
Application NumberANDA070772
Product Classification
M
Marketing Category
C73584
G
Generic Name
metronidazole
Product Specifications
Route of AdministrationORAL
Effective DateMarch 13, 2021
FDA Product Classification
INGREDIENTS (6)
METRONIDAZOLEActive
Quantity: 500 mg in 1 1
Code: 140QMO216E
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
metronidazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69292-207
Application NumberANDA070772
Product Classification
M
Marketing Category
C73584
G
Generic Name
metronidazole
Product Specifications
Route of AdministrationORAL
Effective DateMarch 13, 2021
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
METRONIDAZOLEActive
Quantity: 250 mg in 1 1
Code: 140QMO216E
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT