Over-the-counter drug · OTC MONOGRAPH DRUG
Zeasorb Athletes Foot (Miconazole nitrate) NDC 0316-8000
Miconazole nitrate 20 mg/g · Powder · Topical · Crown Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0316-8000-01 | 0031680000100316800001 | 71 g in 1 BOTTLE, PLASTIC (0316-8000-01)Marketed from Oct 19, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Zeasorb Athletes Foot
- Generic name (nonproprietary)
- miconazole nitrate
- Active ingredients
- Miconazole nitrate — 20 mg/g
- Dosage form
- Powder
- Route
- Topical
- Labeler
- Crown LaboratoriesNDC labeler code 0316
- 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 0316-8000_48340802-e215-04b8-e063-6394a90ad0fcSPL ID 48340802-e215-04b8-e063-6394a90ad0fcSPL set ID 09bb313e-90cb-5629-e063-6294a90ac268RxCUI 998461, 1437793UNII VW4H1CYW1K
- 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
N400316800001followed by a unit qualifier and the quantityPackage 00316-8000-01. 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)
Use Proven clinically effective in the treament of most athlete's foot
Excerpt only. Read the full label for complete information.
About NDC 0316-8000
- What is NDC 0316-8000?
- 0316-8000 is the product NDC for Zeasorb Athletes Foot (miconazole nitrate), Miconazole nitrate 20 mg/g powder, listed with the FDA by Crown Laboratories. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zeasorb Athletes Foot (Miconazole nitrate).
- What is the active ingredient?
- Miconazole nitrate.
- Who is the labeler?
- Crown Laboratories, NDC labeler code 0316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zeasorb Athletes Foot?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
|---|---|---|---|---|
| Terrasil Tinea Treatment MAXclotrimazole | Clotrimazole 1 g/100g | OintmentTopical | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 24909-104 |
| Everywhere Flushable Wipes | Benzalkonium chloride .15 U/100U | ClothTopical | Shenzhen Shierjie Biological Engineering Co., LTD | 43116-042 |
| Seacall Hydrocortisone Ointment.seacall hydrocortisone ointment | Hydrocortisone .1 g/100g | OintmentTopical | Guangdong Quadrant Ecological Technology Co., Ltd. | 76986-006 |
| Fungal Nail Nighttime Renewal Patchestolnaftate 1% | Tolnaftate 1 g/1001 | PatchTopical | 100 KARMA INC | 85569-009 |
| Oiangna Tea Tree Oil Antifungalclotrimazole 1% | Clotrimazole 1 g/116g | SoapTopical | Guangzhou Huixue Biotechnology Co., Ltd. | 87204-285 |
| Eyelid Wipes | 4-terpineol .003 U/100U; Melaleuca alternifolia (Tea tree) leaf oil .04 U/100U | ClothTopical | Shenzhen Shierjie Biological Engineering Co., LTD | 43116-040 |
| CAREALL Clotrimazoleclotrimazole | Clotrimazole 10 g/g | CreamTopical | New World Imports, Inc | 51824-063 |
| Clotrimazole | Clotrimazole 1 g/100g | CreamTopical | Cardinal Health 110 dba LEADER | 70000-0667 |
| Gemachlich ZuHause Fungal Nail Revitalizer | Undecylenic acid 11 g/100mL | LiquidTopical | Guangdong Quadrant Ecological Technology Co., Ltd. | 76986-007 |
| Treatonic Toenail Fungus Treatment Kittoenail fungus treatment | — | KitTopical | 100 KARMA INC | 85569-010 |
| Fungal Nail Treatmentglacial acetic acid | Acetic acid 10.5 g/100mL | LiquidTopical | Guchutang Biotechnology (Longyan) Co., Ltd | 87083-020 |
| Good Neighbor Pharmacy Clotrimazoleclotrimazole | Clotrimazole 10 mg/g | CreamTopical | AmerisourceBergen | 24385-205 |
| Terrasil Ringworm Treatment MAXclotrimazole | Clotrimazole 1 g/100g | OintmentTopical | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 24909-102 |
| Clotrimazolefamily wellness clotrimazole | Clotrimazole 1 g/100g | CreamTopical | Trifecta Pharmaceuticals USA LLC | 69396-038 |
| Paume Moisturizing Antibacterial Hand Gelalcohol | Alcohol 69 mL/100mL | GelTopical | Paume Inc | 80328-123 |
| Viachs ANTIFUNGAL Creammiconazole nitrate 2% antifungal cream | Miconazole nitrate 2 g/100g | CreamTopical | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 87786-044 |
| Clotrimazole | Clotrimazole 1 g/100g | CreamTopical | A-S Medication Solutions | 50090-6546 |
| RoyceDerm ANTIFUNGAL .soap.clotrimazole 1% | Clotrimazole 2.26 g/226g | SoapTopical | RoyceDerm LLC | 85424-019 |
| 1% ketoconazole anti dandruff1% ketoconazole anti dandruff shampoo | Ketoconazole 1 g/100mL | ShampooCutaneous | Fast Sold LLC | 86241-110 |
| Charmpoo ANTIFUNGAL BODY Creammiconazole nitrate 2% antifungal body cream | Miconazole nitrate 2 g/100g | CreamTopical | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 87786-042 |
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