Oravig
- Product NDC
- 61825-303
- 11-digit product format
- 618250303
- Labeler code
- 61825
- Product ID
- 61825-303_47da8a7f-0d47-f1cd-e063-6394a90a84ad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Miconazole
- Dosage form
- TABLET
- Route
- BUCCAL
- Labeler
- Galt Pharmaceuticals, LLC
- Application
- NDA022404
- Marketing category
- NDA
- Marketing start
- 2021-12-31
- Substance
- MICONAZOLE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oravig
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MICONAZOLE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7NNO0D7S5M |
| Rxcui | 998548, 998550 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61825-303-14 | Oravig | 14 in 1 BOTTLE | TABLET | 14 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61825-303 | ORAVIG (MICONAZOLE) TABLET [GALT PHARMACEUTICALS, LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240110_dc2427ff-e566-4b48-b289-9e51c011250a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 61825-303-14 | 61825030314 | 14 TABLET in 1 BOTTLE (61825-303-14) | 14 tablet | 2021-12-31 | 0000-00-00 | No | No | Current |