vagisil brand vagistat
- Product NDC
- 11509-0825
- 11-digit product format
- 115090825
- Labeler code
- 11509
- Product ID
- 11509-0825_42a55863-e89f-4ec0-97a0-2d7b1e2b6b36
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Miconazole nitrate
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- Combe Incorporated
- Application
- ANDA074760
- Marketing category
- ANDA
- Marketing start
- 2020-10-08
- Substance
- MICONAZOLE NITRATE
- Active strength
- 2 g/100g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- vagisil brand vagistat
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MICONAZOLE NITRATE | 2 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VW4H1CYW1K |
| Rxcui | 998540, 1359442 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 11509-0825-1 | vagisil brand vagistat | 1 in 1 CARTON | CREAM | 1 | | 3 |
| 11509-0825-1 | vagisil brand vagistat | 45 g in 1 TUBE | CREAM | 45 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11509-0825 | VAGISIL BRAND VAGISTAT (MICONAZOLE NITRATE) CREAM [COMBE INCORPORATED] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250419_833a5e4d-0591-4300-8f9c-fd00ffaf6041.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 |
|---|
| 11509-0825-1 | 11509082501 | 1 TUBE in 1 CARTON (11509-0825-1) / 45 g in 1 TUBE | 1 tube | 2020-10-08 | 0000-00-00 | No | No | Current |