VAGISTAT
- Product NDC
- 11509-0426
- 11-digit product format
- 115090426
- Labeler code
- 11509
- Product ID
- 11509-0426_8c436269-2f52-4ddf-b3be-cec3069a8865
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Tioconazole
- Dosage form
- OINTMENT
- Route
- VAGINAL
- Labeler
- Combe Incorporated
- Application
- ANDA075915
- Marketing category
- ANDA
- Marketing start
- 2020-07-29
- Substance
- TIOCONAZOLE
- Active strength
- 6.5 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
- VAGISTAT
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TIOCONAZOLE | 6.5 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | S57Y5X1117 |
| Rxcui | 198380, 1550534 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 11509-0426-1 | VAGISTAT | 1 in 1 CARTON | OINTMENT | 1 | | 3 |
| 11509-0426-1 | VAGISTAT | 1 in 1 POUCH | OINTMENT | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11509-0426 | VAGISTAT (TIOCONAZOLE) OINTMENT [COMBE INCORPORATED] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240702_da8eaa33-4195-487f-a234-472dd1036225.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 |
|---|
| 11509-0426-1 | 11509042601 | 1 POUCH in 1 CARTON (11509-0426-1) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR | 1 pouch | 2020-07-29 | 0000-00-00 | No | No | Current |