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Metronidazole

METRONIDAZOLE Topical Cream 0.75%

Approved
Approval ID

33a06972-62b7-4131-81da-77ae692b4869

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 17, 2009

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

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 Code54868-5655
Application NumberANDA076408
Product Classification
M
Marketing Category
C73584
G
Generic Name
metronidazole
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 20, 2010
FDA Product Classification

INGREDIENTS (8)

BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
METRONIDAZOLEActive
Quantity: 7.5 mg in 1 g
Code: 140QMO216E
Classification: ACTIB
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT

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Metronidazole - FDA Drug Approval Details