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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

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Oravig - FDA Drug Approval Details