Metronidazole
METRONIDAZOLE CREAM 1%
Approved
Approval ID
cdf2e251-4bbc-4434-9b00-bef6284491e4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 21, 2022
Manufacturers
FDA
Oceanside Pharmaceuticals
DUNS: 832011691
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 Code68682-202
Application NumberNDA020743
Marketing CategoryC73594
Route of AdministrationTOPICAL
Effective DateJune 21, 2022
Generic Namemetronidazole
INGREDIENTS (8)
metronidazoleActive
Quantity: 10 mg in 60 g
Code: 140QMO216E
Classification: ACTIB
waterInactive
Code: 059QF0KO0R
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
glyceryl monostearateInactive
Code: 230OU9XXE4
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
trolamineInactive
Code: 9O3K93S3TK
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT