Metronidazole
Metronidazole Tablets USP Rx only
Approved
Approval ID
e5bf5579-4f9c-f2b1-e053-2995a90ae497
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 16, 2022
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-2809
Application NumberANDA203974
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metronidazole
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 16, 2022
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
METRONIDAZOLEActive
Quantity: 250 mg in 1 1
Code: 140QMO216E
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT