Over-the-counter drug · OTC MONOGRAPH DRUG
Clotrimazole NDC 10135-671
Clotrimazole 1 g/mL · Solution · Topical · Marlex Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10135-671-81 | 10135067181 | 1 BOTTLE in 1 CARTON (10135-671-81) / 10 mL in 1 BOTTLEMarketed from Dec 1, 2018 | |
| 10135-671-91 | 10135067191 | 1 BOTTLE in 1 CARTON (10135-671-91) / 30 mL in 1 BOTTLEMarketed from Feb 1, 2020 |
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
- Generic name (nonproprietary)
- clotrimazole
- Active ingredients
- Clotrimazole — 1 g/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Marlex Pharmaceuticals IncNDC labeler code 10135
- 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 10135-671_40a87948-bcf6-0552-e063-6394a90a2d0dSPL ID 40a87948-bcf6-0552-e063-6394a90a2d0dSPL set ID d6e95c99-e055-436a-8ee6-40d6e199eacaUNII 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
N410135067181followed by a unit qualifier and the quantityPackage 10135-0671-81. 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 (tinea pedis) Jock Itch (tinea cruris) Ringworm (tinea corporis) Effectively relieves Itching Cracking Burning Discomfort which can accompany these conditions
Excerpt only. Read the full label for complete information.
About NDC 10135-671
- What is NDC 10135-671?
- 10135-671 is the product NDC for Clotrimazole, Clotrimazole 1 g/mL solution, listed with the FDA by Marlex Pharmaceuticals Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clotrimazole.
- What is the active ingredient?
- Clotrimazole.
- Who is the labeler?
- Marlex Pharmaceuticals Inc, NDC labeler code 10135. 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?
- 64 other product NDCs are listed under this name. See all Clotrimazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clotrimazole 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 | Clotrimazole 1 g/mL | SolutionTopical | InvaDerm Corporation | 71457-523 | 71457-0523-1071457-0523-30 |
| Clotrimazole | Clotrimazole 1 g/100g | CreamVaginal | YYBA CORP | 73581-450 | 73581-0450-01 |
| Clotrimazole | Clotrimazole 1 g/mL | SolutionTopical | YYBA CORP | 73581-448 | 73581-0448-30 |
| Clotrimazole | Clotrimazole 100 kg/100kg | GranuleTopical | Shaanxi Shuvita Biotech Co., Ltd | 87879-001 | 87879-0001-01 |
| Clotrimazole | Clotrimazole 10 mg/mL | SolutionTopical | Preferred Pharmaceuticals Inc. | 68788-4155 | 68788-4155-03 |
| Clotrimazole | Clotrimazole 1 g/mL | SolutionTopical | Preferred Pharmaceuticals Inc. | 68788-4080 | 68788-4080-01 |
| Clotrimazole | Clotrimazole 1 g/mL | SolutionTopical | AvPAK | 50268-044 | 50268-0044-30 |
| Clotrimazole | Clotrimazole 10 mg/g | CreamVaginal | Cardinal Health (Leader) 70000 | 70000-0729 | 70000-0729-01 |
| Clotrimazole | Clotrimazole 1 g/100g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8830 | 68788-8830-02 |
| Clotrimazole | Clotrimazole 1 g/100mL | SolutionTopical | Rugby Laboratories, Inc. | 0536-1443 | 00536-1443-70 |
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 |
|---|---|---|---|---|
| Antifungal Liquidtolnaftate | Tolnaftate 10 mg/mL | LiquidTopical | Target Corporation | 82442-998 |
| Tolnafatetolnaftate powder spray | Tolnaftate 10 mg/g | Aerosol, SprayTopical | Meijer Distribution Inc. | 79481-0607 |
| Antifungalclotrimazole | Clotrimazole 1 g/100g | CreamTopical | VIVE HEALTH LLC | 84722-3059 |
| Hermon Antifungal Cleansing Bartolnaftate 1% | Tolnaftate 4.52 g/452g | SoapTopical | Beautivity LLC | 85398-029 |
| Osimoon Fungal Nail Renewalfungal nail renewal | Undecylenic acid 10 g/100mL | LiquidTopical | Guangzhou Jingliang Cosmetics Co., Ltd. | 87408-006 |
| Suave Antibacterial Hand Wash Sea Minerals and Aloe Veraliquid hand wash antibacterial | Benzalkonium chloride .13 g/100mL | LiquidTopical | Suave Brands Co, LLC | 83711-407 |
| Hermon Ringworm Antifungal soap.clotrimazole 1% | Clotrimazole 2.3 g/230g | SoapTopical | Beautivity LLC | 85398-026 |
| Anytalk FUNGAL NAIL TREATMENTtolnaftate 1% | Tolnaftate .01 mg/15mL | LiquidTopical | Guangzhou Huixue Biotechnology Co., Ltd. | 87204-181 |
| Tuymec FUNGAL NAIL TREATMENT Kitfungal nail treatment kit | Undecylenic acid 10 g/100mL | LiquidTopical | Guangzhou Jingliang Cosmetics Co., Ltd. | 87408-004 |
| Antifungal Creammiconazole nitrate | Miconazole nitrate 2 g/100g | CreamTopical | Encube Ethicals, Inc. | 21922-095 |
| Hand Sanitizerethyl alcohol | Alcohol 62 mL/100mL | GelTopical | Orazen Inc | 71927-005 |
| Jock Itchmiconazole nitrate | Miconazole nitrate 20 mg/g | Aerosol, SprayTopical | Meijer Distribution Inc. | 79481-0602 |
| Antifungal Liquidtolnaftate | Tolnaftate 10 mg/mL | LiquidTopical | Wal-Mart Stores, Inc. | 79903-256 |
| 5% Benzoyl Peroxide FOLLICULITIS Cream | Benzoyl peroxide 5 g/100g | CreamTopical | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 84558-026 |
| Hermon Ringworm Treatment Kitmiconazole nitrate 2% and clotrimazole 1% | — | KitTopical | Beautivity LLC | 85398-027 |
| Kroger Jock Itchclotrimazole | Clotrimazole 10 mg/g | CreamTopical | Kroger Company | 30142-510 |
| DCH Labs Antifungal Jockmiconazole nitrate 2% | Miconazole nitrate 2 g/100g | PowderTopical | Derma Care Research Labs, LLC | 72839-096 |
| FFPMAM Antifungal Cream | Clotrimazole 1 g/100g | CreamTopical | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 84558-027 |
| Antifungalmiconazole | Miconazole 2 g/100g | PowderTopical | VIVE HEALTH LLC | 84722-3057 |
| Serynth Antifungal Nail Treatment Penundecylenic acid 25% antifungal nail treatment pen | Undecylenic acid 25 g/100mL | LiquidTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-165 |
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