Topco Miconazole 3
- Product NDC
- 36800-782
- 11-digit product format
- 368000782
- Labeler code
- 36800
- Product ID
- 36800-782_6381c9e2-ff95-42f8-8b4f-0031692f5931
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- miconazole nitrate
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- Topco Associates LLC
- Application
- ANDA091366
- Marketing category
- ANDA
- Marketing start
- 2020-04-27
- Substance
- MICONAZOLE NITRATE
- Active strength
- 40 mg/g
- 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
- Topco Miconazole 3
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MICONAZOLE NITRATE | 40 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VW4H1CYW1K |
| Rxcui | 998544, 2288429 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-782-14 | Topco Miconazole 3 | 5 g in 1 APPLICATOR | CREAM | 5 | | 3 |
| 36800-782-14 | Topco Miconazole 3 | 3 in 1 CARTON | CREAM | 3 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-782 | TOPCO MICONAZOLE 3 (MICONAZOLE NITRATE) CREAM [TOPCO ASSOCIATES LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20210216_aef7be88-3cd7-484b-96a3-e9bbeca55e2a.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 |
|---|
| 36800-782-14 | 36800078214 | 3 APPLICATOR in 1 CARTON (36800-782-14) / 5 g in 1 APPLICATOR | 3 applicator | 2020-04-27 | 0000-00-00 | No | No | Current |