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NORITATE

Approved
Approval ID

1787c491-d92c-4239-9d9f-6a91b629835d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 6, 2011

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 Code54868-4449
Application NumberNDA020743
Product Classification
M
Marketing Category
C73594
G
Generic Name
metronidazole
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 6, 2011
FDA Product Classification

INGREDIENTS (8)

PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
METRONIDAZOLEActive
Quantity: 10 mg in 1 g
Code: 140QMO216E
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT

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NORITATE - FDA Drug Approval Details