Over-the-counter drug · OTC MONOGRAPH DRUG
Clotrimazole NDC 69396-087
Clotrimazole 1 g/100g · Cream · Topical · TRIFECTA PHARMACEUTICALS USA LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69396-087-01 | 6939600870169396008701 | 1 TUBE in 1 BOX (69396-087-01) / 28.4 g in 1 TUBEMarketed from Jun 4, 2022 | |
| 69396-087-55 | 6939600875569396008755 | 5 TUBE in 1 BOX (69396-087-55) / 28.4 g in 1 TUBEMarketed from Apr 8, 2022 |
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/100g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- TRIFECTA PHARMACEUTICALS USA LLCNDC labeler code 69396
- 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 69396-087_4bf9a459-7b08-9a01-e063-6294a90ac7b9SPL ID 4bf9a459-7b08-9a01-e063-6294a90ac7b9SPL set ID e0a2a907-9c3a-4c4e-e053-2995a90abb91RxCUI 309367UNII G07GZ97H65UPC 0094922042002
- 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
N469396008701followed by a unit qualifier and the quantityPackage 69396-0087-01. 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 athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.
Excerpt only. Read the full label for complete information.
About NDC 69396-087
- What is NDC 69396-087?
- 69396-087 is the product NDC for Clotrimazole, Clotrimazole 1 g/100g cream, listed with the FDA by TRIFECTA PHARMACEUTICALS USA LLC. 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?
- TRIFECTA PHARMACEUTICALS USA LLC, NDC labeler code 69396. 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?
- 63 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/mL | SolutionTopical | YYBA CORP | 73581-448 | 73581-0448-30 |
| Clotrimazole | Clotrimazole 1 g/100g | CreamVaginal | YYBA CORP | 73581-450 | 73581-0450-01 |
| 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 |
|---|---|---|---|---|
| Lavender Foot and Shoe Antifungalundecylenic acid 10% | Undecylenic acid 10 g/100mL | SprayTopical | SANSAR, LLC | 83691-015 |
| Sefudun Fungal Nail Patchesglycerin | Glycerin .01 g/1 | PatchTopical | Shenzhen Shandian Jingling Technology Co., Ltd. | 83804-006 |
| Hongo Killertolnaftate | Miconazole nitrate .2 g/10g | Aerosol, SprayTopical | Efficient Laboratories Inc | 58593-625 |
| Lights Isopropyl Alcohol Prep Padsisopropyl alcohol | Isopropyl alcohol 70 mL/100mL | SolutionTopical | Lights Medical Manufacture Co., Ltd. | 61333-206 |
| Miconazole Nitrate | Miconazole nitrate 20 mg/g | CreamTopical | STRATEGIC SOURCING SERVICES LLC | 70677-1000 |
| Tolnaftatemeijer athletes foot liquid spray | Tolnaftate 1.5 g/150g | Aerosol, SprayTopical | Meijer Distribution Inc. | 79481-0591 |
| Mint Blast Foot and Shoe Antifungalundecylenic acid 10% | Undecylenic acid 10 g/100mL | SprayTopical | SANSAR, LLC | 83691-013 |
| NATURAL CURES FUNGAL NAIL Patchestolnaftate 1% fungal nail patches | Tolnaftate 1 g/1001 | PatchTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-202 |
| Benzo Dermabenzoic acid, salicylic acid, sulfur | Salicylic acid 2.5 g/100g + 2 more ingredients | CreamTopical | LABORATORIOS H.G. C.A. | 84058-130 |
| SUNMARK MICONAZOLE NITRATE antifungalmiconazole nitrate | Miconazole nitrate 20 mg/g | CreamTopical | Strategic Sourcing Services LLC | 49348-689 |
| Hongo Killertolnaftate | Tolnaftate 1 g/100g | PowderTopical | Efficient Laboratories Inc | 58593-288 |
| Mycozyl ALtolnaftate | Tolnaftate .3 g/30mL | LiquidTopical | PureTek Corporation | 59088-443 |
| Tolnaftate Cream 1%tolnaftate | Tolnaftate 10 mg/g | CreamTopical | Pharmacy Value Alliance, LLC. | 68016-152 |
| Citrus Detox Foot and Shoe Antifungalundecylenic acid 10% | Undecylenic acid 10 g/100mL | SprayTopical | SANSAR, LLC | 83691-014 |
| Antifungal Ringworm Treatmentmiconazole nitrate | Miconazole nitrate 2 g/100mL | SprayTopical | Rida LLC | 83004-030 |
| Jock-Ezeclotrimazole | Clotrimazole 10 mg/g | CreamTopical | Bentlin Products LLC | 47832-071 |
| Maximum Strength Antifungal Liquidtolnaftate | Tolnaftate 10 mg/mL | LiquidTopical | Walgreens Company | 0363-2026 |
| QualiLife persimmon foot and shoeundecylenic acid | Undecylenic acid 10 g/100mL | SprayTopical | Guangdong Aimu Biological Technology Co., Ltd | 83566-618 |
| Terramed Just Think Comfort Armor Antifungal Body Wash Tea Treetolnaftate | Tolnaftate 1 g/100g | GelTopical | Rida LLC | 83004-032 |
| Kakalsa TOENAIL FUNGUS TREATMENTundecylenic acid 25% toenail fungus treatment | Undecylenic acid 25 g/100mL | LiquidTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-204 |
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