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NDC 61825-0303-14 Oravig 50 mg/1 Details
Oravig 50 mg/1
Oravig is a BUCCAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Galt Pharmaceuticals, LLC. The primary component is MICONAZOLE.
MedlinePlus Drug Summary
Buccal miconazole is used to treat yeast infections of the mouth and throat in adults and children 16 years of age and older. Miconazole buccal is in a class of medications called imidazoles. It works by stopping the growth of fungi that cause infection.
Related Packages: 61825-0303-14Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Miconazole Buccal
Product Information
| NDC | 61825-0303 |
|---|---|
| Product ID | 61825-303_0e7b8449-3f4c-4045-e063-6394a90aaca2 |
| Associated GPIs | 88100060000310 |
| GCN Sequence Number | 063921 |
| GCN Sequence Number Description | miconazole MA BUC TAB 50 MG BUCCAL |
| HIC3 | W3B |
| HIC3 Description | ANTIFUNGAL AGENTS |
| GCN | 99633 |
| HICL Sequence Number | 004139 |
| HICL Sequence Number Description | MICONAZOLE |
| Brand/Generic | Brand |
| Proprietary Name | Oravig |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Miconazole |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | BUCCAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/1 |
| Substance Name | MICONAZOLE |
| Labeler Name | Galt Pharmaceuticals, LLC |
| Pharmaceutical Class | Azole Antifungal [EPC], Azoles [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA022404 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 61825-0303-14 (61825030314)
| NDC Package Code | 61825-303-14 |
|---|---|
| Billing NDC | 61825030314 |
| Package | 14 TABLET in 1 BOTTLE (61825-303-14) |
| Marketing Start Date | 2021-12-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |