Prescription drug · ANDA
Clotrimazole Topical Solution USP, 1% NDC 52817-800
Clotrimazole 10 mg/mL · Solution · Topical · TruPharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52817-800-30 | 5281708003052817080030 | 1 BOTTLE in 1 CARTON (52817-800-30) / 30 mL in 1 BOTTLEMarketed from Jul 25, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- TruPharma LLCNDC labeler code 52817
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212281
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 52817-800_48ab26b2-908a-43d1-e063-6394a90a2cb5SPL ID 48ab26b2-908a-43d1-e063-6394a90a2cb5SPL set ID 1d2354f2-edfd-4be7-9550-760958eb36eeRxCUI 309370UNII G07GZ97H65UPC 0352817800305
- 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
N452817080030followed by a unit qualifier and the quantityPackage 52817-0800-30. 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.
About NDC 52817-800
- What is NDC 52817-800?
- 52817-800 is the product NDC for Clotrimazole Topical Solution USP, 1%, Clotrimazole 10 mg/mL solution, listed with the FDA by TruPharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clotrimazole Topical Solution USP, 1%.
- What is the active ingredient?
- Clotrimazole.
- Who is the labeler?
- TruPharma LLC, NDC labeler code 52817. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Clotrimazole Topical Solution USP, 1%?
- 4 other product NDCs are listed under this name. See all Clotrimazole Topical Solution USP, 1% NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clotrimazole Topical Solution USP, 1% products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Clotrimazole Topical Solution USP, 1% | Clotrimazole 10 mg/mL | SolutionTopical | Allegis Holdings, LLC | 71297-030 | 71297-0030-02 |
| Clotrimazole Topical Solution USP, 1% | Clotrimazole 10 mg/mL | SolutionTopical | ScieGen Pharmaceuticals, Inc | 50228-502 | 50228-0502-0850228-0502-3050228-0502-31 |
| Clotrimazole Topical Solution USP, 1% | Clotrimazole 10 mg/mL | SolutionTopical | Akron Pharma Inc. | 71399-0666 | 71399-0666-0371399-0666-06 |
| Clotrimazole Topical Solution USP, 1% | Clotrimazole 10 mg/mL | SolutionTopical | Bryant Ranch Prepack | 72162-2178 | 72162-2178-03 |
Other NDCs under ANDA 212281
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 | Bryant Ranch Prepack | 72162-2178 |