Over-the-counter drug · OTC MONOGRAPH DRUG
Fortinia (Clotrimazole) NDC 54633-314
Clotrimazole 10 mg/g · Cream · Topical · The Podiatree Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54633-314-80 | 54633031480 | 80 g in 1 BOTTLE, PUMP (54633-314-80)Marketed from Feb 2, 2015 |
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)
- Fortinia
- Generic name (nonproprietary)
- clotrimazole
- Active ingredients
- Clotrimazole — 10 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- The Podiatree CompanyNDC labeler code 54633
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 005
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 54633-314_47e362c2-c358-adbe-e063-6294a90a6043SPL ID 47e362c2-c358-adbe-e063-6294a90a6043SPL set ID 60ba6f8a-8617-d4f6-e053-2991aa0a4a71RxCUI 309367UNII 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
N454633031480followed by a unit qualifier and the quantityPackage 54633-0314-80. 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)
Uses • cures most athlete’s foot infections and ringworm infections • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
Excerpt only. Read the full label for complete information.
About NDC 54633-314
- What is NDC 54633-314?
- 54633-314 is the product NDC for Fortinia (clotrimazole), Clotrimazole 10 mg/g cream, listed with the FDA by The Podiatree Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fortinia (Clotrimazole).
- What is the active ingredient?
- Clotrimazole.
- Who is the labeler?
- The Podiatree Company, NDC labeler code 54633. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fortinia?
- 1 other product NDC are listed under this name. See all Fortinia NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fortinia products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fortiniaclotrimazole 1% | Clotrimazole 1 g/100mL | SolutionTopical | The Podiatree Company | 54633-214 | 54633-0214-01 |
Other NDCs under M 005
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 |
|---|---|---|---|---|
| Hermon Antifungal .soap.tolnaftate 1% | Tolnaftate 10 mg/g | SoapTopical | Beautivity LLC | 85398-025 |
| Terrasil Ringworm Treatment MAXclotrimazole | Clotrimazole 1 g/100g | OintmentTopical | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 24909-102 |
| Tolnaftatefoot odor control powder spray | Tolnaftate 1.3 g/113g | Aerosol, SprayTopical | Meijer Distribution Inc | 41250-635 |
| Hermon Jock Itch Antifungal Treatment Kit Antifungal Cream and .Soap. for Jock Itchantifungal treatment kit | — | KitTopical | Beautivity LLC | 85398-022 |
| Tolfyratolnaftate | Tolnaftate .3 g/30mL | LiquidTopical | Oncora Pharma, LLC | 85477-331 |
| Miconazole Nitratejock itch spray | Miconazole nitrate 1.3 g/130g | Aerosol, SprayTopical | Harris Teeter, LLC | 69256-038 |
| FFPMAM Antifungal Cream | Clotrimazole 1 g/100g | CreamTopical | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 84558-027 |
| Good Neighbor Pharmacy Clotrimazoleclotrimazole | Clotrimazole 10 mg/g | CreamTopical | AmerisourceBergen | 24385-205 |
| terrasil Folliculitis Cream Maximum Strengthclotrimazole | Clotrimazole 1 g/100g | CreamTopical | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 24909-064 |
| Anti-fungal Powder Miconazole Nitratemiconazole nitrate | Miconazole nitrate 20 mg/g | PowderTopical | Premier Brands of America Inc. | 56104-500 |
| Miconazole Nitrateathletes foot powder spray talc free | Miconazole nitrate 2.6 g/130g | Aerosol, PowderTopical | Harris Teeter, LLC | 69256-039 |
| Ringworm Treatment Creammiconazole nitrate 2% | Miconazole nitrate 2 g/100g | CreamTopical | Beautivity LLC | 85398-024 |
| Eye CareSprayeyelid cleansing spray | Melaleuca alternifolia (Tea tree) leaf oil .001 U/100mL; 4-terpineol .002 U/100mL | SolutionOphthalmic | Shenzhen Shierjie Biological Engineering Co., LTD | 43116-051 |
| Leader Athletes Foot Clotrimazoleclotrimazole | Clotrimazole .01 g/g | CreamTopical | LEADER | 70000-0542 |
| APUREE Maximum Strength Athletes Foot Antifungal | Miconazole nitrate .02 g/1 | CreamTopical | Guangzhou Meixi Biotechnology Co., Ltd. | 84167-170 |
| Life66II Antifungal Nailundecylenic acid 25% antifungal nail | Undecylenic acid 25 g/100mL | LiquidTopical | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 87786-058 |
| Kroger Jock Itchclotrimazole | Clotrimazole 10 mg/g | CreamTopical | Kroger Company | 30142-510 |
| Tolnaftateantifungal liquid spray | Tolnaftate 1.5 g/150g | Aerosol, SprayTopical | ARMY & AIR FORCE EXCHANGE SERVICE | 55301-131 |
| Zeasorb Jock Itchmiconazole nitrate | Miconazole nitrate 20 mg/g | PowderTopical | Crown Laboratories | 0316-8001 |
| Clotrimazole 1% Athletes Footclotrimazole | Clotrimazole 10 mg/g | CreamTopical | STRATEGIC SOURCING SERVICES LLC | 70677-1002 |
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