AZOLEN
- Product NDC
- 58980-819
- 11-digit product format
- 589800819
- Labeler code
- 58980
- Product ID
- 58980-819_85b974c1-bef2-4320-93a4-0fcf7774c55c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MICONAZOLE NITRATE
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- STRATUS PHARMACEUTICALS INC
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-09-14
- Substance
- MICONAZOLE NITRATE
- Active strength
- 2 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
- AZOLEN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MICONAZOLE NITRATE | 2 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VW4H1CYW1K |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58980-819-60 | AZOLEN | 170 g in 1 BOTTLE | LIQUID | 170 | | 2 |
| 58980-819-60 | AZOLEN | 1 in 1 BOX | LIQUID | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58980-819 | AZOLEN (MICONAZOLE NITRATE) LIQUID [STRATUS PHARMACEUTICALS INC] | 2 | Current NDC, 2 package rows | 20241102_3264bd0a-c628-404b-8c09-8586682d054e.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58980-819-60 | 58980081960 | 1 BOTTLE in 1 BOX (58980-819-60) / 170 g in 1 BOTTLE | 1 bottle | 2023-09-14 | No | No | Current |