CLOTRIMAZOLE
- Product NDC
- 0536-1443
- 11-digit product format
- 005361443
- Labeler code
- 0536
- Product ID
- 0536-1443_51921fa3-cebb-5959-e063-6294a90aaca2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- CLOTRIMAZOLE
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Rugby Laboratories, Inc.
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-11-21
- Substance
- CLOTRIMAZOLE
- Active strength
- 1 g/100mL
- 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLOTRIMAZOLE | 1 g/100mL |
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 |
|---|
| 0536-1443-70 | CLOTRIMAZOLE | 1 in 1 CARTON | SOLUTION | 1 | | 4 |
| 0536-1443-70 | CLOTRIMAZOLE | 10 mL in 1 BOTTLE | SOLUTION | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0536-1443 | CLOTRIMAZOLE SOLUTION [RUGBY LABORATORIES, INC.] | 2 | Current NDC, 2 package rows | 20241129_2c60e631-5930-4420-886d-eb1990c720b6.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 |
|---|
| 0536-1443-70 | 00536144370 | 1 BOTTLE in 1 CARTON (0536-1443-70) / 10 mL in 1 BOTTLE | 1 bottle | 2024-11-21 | No | No | Historical |