Clotrimazole Topical Solution USP, 1%
- Product NDC
- 50228-502
- 11-digit product format
- 502280502
- Labeler code
- 50228
- Product ID
- 50228-502_50b252b4-beb8-3d5a-e063-6394a90a3490
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clotrimazole Topical Solution USP, 1%
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- ScieGen Pharmaceuticals, Inc
- Application
- ANDA216569
- Marketing category
- ANDA
- Marketing start
- 2023-10-16
- Substance
- CLOTRIMAZOLE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clotrimazole Topical Solution USP, 1%
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLOTRIMAZOLE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G07GZ97H65 |
| Rxcui | 309370 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50228-502-08 | Clotrimazole Topical Solution USP, 1% | 10 mL in 1 BOTTLE | SOLUTION | 10 | | 6 |
| 50228-502-08 | Clotrimazole Topical Solution USP, 1% | 1 in 1 CARTON | SOLUTION | 1 | | 6 |
| 50228-502-30 | Clotrimazole Topical Solution USP, 1% | 1 in 1 CARTON | SOLUTION | 1 | | 6 |
| 50228-502-30 | Clotrimazole Topical Solution USP, 1% | 30 mL in 1 BOTTLE | SOLUTION | 30 | | 6 |
| 50228-502-31 | Clotrimazole Topical Solution USP, 1% | 30 mL in 1 BOTTLE | SOLUTION | 30 | | 6 |
| 50228-502-31 | Clotrimazole Topical Solution USP, 1% | 1 in 1 CARTON | SOLUTION | 1 | | 6 |
| 50228-502-61 | Clotrimazole Topical Solution USP, 1% | 2 in 1 CARTON | SOLUTION | 2 | | 6 |
| 50228-502-61 | Clotrimazole Topical Solution USP, 1% | 30 mL in 1 BOTTLE | SOLUTION | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50228-502 | CLOTRIMAZOLE TOPICAL SOLUTION USP, 1% SOLUTION [SCIEGEN PHARMACEUTICALS, INC] | 4 | Current NDC, 8 package rows | 20240312_15368c2a-572f-41fb-a3a1-7b1eb842faa8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50228-502-08 | 50228050208 | 1 BOTTLE in 1 CARTON (50228-502-08) / 10 mL in 1 BOTTLE | 1 bottle | 2023-10-16 | No | No | Current |
| 50228-502-30 | 50228050230 | 1 BOTTLE in 1 CARTON (50228-502-30) / 30 mL in 1 BOTTLE | 1 bottle | 2023-10-16 | No | No | Current |
| 50228-502-31 | 50228050231 | 1 BOTTLE in 1 CARTON (50228-502-31) / 30 mL in 1 BOTTLE | 1 bottle | 2023-10-16 | No | No | Current |
| 50228-502-61 | 50228050261 | 2 in 1 CARTON | | | | | Historical |