Clotrimazole
- Product NDC
- 53002-8400
- 11-digit product format
- 530028400
- Labeler code
- 53002
- Product ID
- 53002-8400_0a165ad5-874b-4872-8cd2-b5817d2cb924
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clotrimazole
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA074580
- Marketing category
- ANDA
- Marketing start
- 1996-07-29
- Marketing end
- 0000-00-00
- Substance
- CLOTRIMAZOLE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Azole Antifungal [EPC],Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-8400-2 | Clotrimazole | 1 in 1 CARTON | SOLUTION | 1 | | 5 |
| 53002-8400-2 | Clotrimazole | 30 mL in 1 BOTTLE, PLASTIC | SOLUTION | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-8400 | CLOTRIMAZOLE SOLUTION [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 2 package rows | 20230609_b67ebafe-0b9d-4fb0-a897-7c9a5691696e.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 |
|---|
| 53002-8400-2 | 53002840002 | 1 BOTTLE, PLASTIC in 1 CARTON (53002-8400-2) > 30 mL in 1 BOTTLE, PLASTIC | 2018-10-01 | 0000-00-00 | No | No | Current |