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