Oravig
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ORAVIG safely and effectively. See full prescribing information for ORAVIG. ORAVIG (miconazole) buccal tablets Initial U.S. Approval: January 1974
Approved
Approval ID
dc2427ff-e566-4b48-b289-9e51c011250a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 2024
Manufacturers
FDA
Galt Pharmaceuticals, LLC
DUNS: 079214973
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Miconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61825-303
Application NumberNDA022404
Product Classification
M
Marketing Category
C73594
G
Generic Name
Miconazole
Product Specifications
Route of AdministrationBUCCAL
Effective DateJanuary 8, 2024
FDA Product Classification
INGREDIENTS (8)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CASEINInactive
Code: 48268V50D5
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICONAZOLEActive
Quantity: 50 mg in 1 1
Code: 7NNO0D7S5M
Classification: ACTIB