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Metronidazole

Metronidazole 500MG Tablets Rx only

Approved
Approval ID

b9c0674b-00c9-5989-e053-2995a90ac1bb

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 15, 2021

Manufacturers
FDA

RedPharm Drug, Inc.

DUNS: 828374897

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 Code67296-1418
Application NumberANDA203974
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateFebruary 15, 2021
Generic NameMetronidazole

INGREDIENTS (7)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
METRONIDAZOLEActive
Quantity: 500 mg in 1 1
Code: 140QMO216E
Classification: ACTIB

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Metronidazole - FDA Drug Approval Details