Topcare Miconazole 7
- Product NDC
- 36800-825
- 11-digit product format
- 368000825
- Labeler code
- 36800
- Product ID
- 36800-825_887383d2-df39-4e9f-9b11-4fa83dc578ce
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Miconazole nitrate
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- Topco Associates LLC
- Application
- ANDA074760
- Marketing category
- ANDA
- Marketing start
- 2000-02-29
- 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
- Topcare Miconazole 7
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-825-29 | Topcare Miconazole 7 | 45 g in 1 TUBE, WITH APPLICATOR | CREAM | 45 | | 4 |
| 36800-825-29 | Topcare Miconazole 7 | 1 in 1 CARTON | CREAM | 1 | | 4 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-825 | TOPCARE MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [TOPCO ASSOCIATES LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20210211_351905b1-f78c-4838-a036-23b2bfc775f2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 36800-825-29 | 36800082529 | 1 TUBE, WITH APPLICATOR in 1 CARTON (36800-825-29) / 45 g in 1 TUBE, WITH APPLICATOR | 2000-02-29 | 0000-00-00 | No | No | Current |