MONISTAT TIOCONAZOLE 1
- Product NDC
- 63736-413
- 11-digit product format
- 637360413
- Labeler code
- 63736
- Product ID
- 63736-413_c7b11d34-bd8a-4c84-aa4c-2cc6cf9037df
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- TIOCONAZOLE
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Insight Pharmaceuticals LLC
- Application
- ANDA075915
- Marketing category
- ANDA
- Marketing start
- 2001-11-21
- 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
- MONISTAT TIOCONAZOLE 1
- 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, 1661176 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63736-413-01 | MONISTAT TIOCONAZOLE 1 | 4.6 g in 1 APPLICATOR | OINTMENT | 4.6 | | 1 |
| 63736-413-01 | MONISTAT TIOCONAZOLE 1 | 1 in 1 CARTON | OINTMENT | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63736-413 | MONISTAT TIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [INSIGHT PHARMACEUTICALS LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20190315_587e42b4-cbdc-4a03-afae-f9e5e6605937.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 |
|---|
| 63736-413-01 | 63736041301 | 1 APPLICATOR in 1 CARTON (63736-413-01) / 4.6 g in 1 APPLICATOR | 1 applicator | 2001-11-21 | 0000-00-00 | No | No | Current |