Prescription drug · ANDA
Clotrimazole Topical Solution USP, 1% NDC 71399-0666
Clotrimazole 10 mg/mL · Solution · Topical · Akron Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71399-0666-3 | 71399066603 | 1 BOTTLE in 1 CARTON (71399-0666-3) / 30 mL in 1 BOTTLEMarketed from May 4, 2024 | |
| 71399-0666-6 | 71399066606 | 2 BOTTLE in 1 CARTON (71399-0666-6) / 30 mL in 1 BOTTLEMarketed from Mar 25, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Clotrimazole Topical Solution USP, 1%
- Generic name (nonproprietary)
- clotrimazole topical solution usp, 1%
- Active ingredients
- Clotrimazole — 10 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Akron Pharma Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216569
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 71399-0666_5fbee99b-e93b-4682-9629-98f4f65587faSPL ID 5fbee99b-e93b-4682-9629-98f4f65587faSPL set ID 32b968ce-e112-441c-a91f-c62f2f67b57cRxCUI 309370UNII G07GZ97H65
- Pharmacologic class
- Azole Antifungal
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471399066603followed by a unit qualifier and the quantityPackage 71399-0666-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Prescription Clotrimazole Topical Solution product is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur . This formulation is also available as a nonprescription product which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes , Epidermophyton fluoccosum , and Microsporum canis .
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216569
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Clotrimazole Topical Solution USP, 1% | Clotrimazole 10 mg/mL | SolutionTopical | ScieGen Pharmaceuticals, Inc | 50228-502 |
| Clotrimazole Topical Solution USP, 1% | Clotrimazole 10 mg/mL | SolutionTopical | Allegis Holdings, LLC | 71297-030 |
| Clotrimazole | Clotrimazole 10 mg/mL | SprayTopical | AARNA USA INC | 82568-0036 |