Topcare Tioconazole 1
- Product NDC
- 36800-426
- 11-digit product format
- 368000426
- Labeler code
- 36800
- Product ID
- 36800-426_d24c0ab3-4644-4b60-90a5-dc1aac6eb6f3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Tioconazole
- Dosage form
- OINTMENT
- Route
- VAGINAL
- Labeler
- Topco Associates LLC
- Application
- ANDA075915
- Marketing category
- ANDA
- Marketing start
- 2008-03-03
- 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
- Topcare 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 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-426-54 | Topcare Tioconazole 1 | 1 in 1 CARTON | OINTMENT | 1 | | 5 |
| 36800-426-54 | Topcare Tioconazole 1 | 1 in 1 POUCH | OINTMENT | 1 | | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-426 | TOPCARE TIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [TOPCO ASSOCIATES LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240817_fce06160-2098-4ac1-9cc3-a584d4f5a51d.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 |
|---|
| 36800-426-54 | 36800042654 | 1 POUCH in 1 CARTON (36800-426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR | 1 pouch | 2008-03-03 | 0000-00-00 | No | No | Current |