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metronidazole

Metronidazole Tablets, USP Rx only

Approved
Approval ID

99886f54-4ebe-4a2d-b779-bcfbb0634db1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 28, 2025

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

metronidazole

PRODUCT DETAILS

NDC Product Code72162-2468
Application NumberANDA070772
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 28, 2025
Generic Namemetronidazole

INGREDIENTS (6)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
METRONIDAZOLEActive
Quantity: 125 mg in 1 1
Code: 140QMO216E
Classification: ACTIB
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metronidazole - FDA Approval | MedPath