Over-the-counter drug · OTC MONOGRAPH DRUG
Triple Antifungal (Miconazole nitrate) NDC 16864-040
Miconazole nitrate 2 g/100g · Ointment · Topical · Advantice Health, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16864-040-02 | 1686400400216864004002 | 1 TUBE in 1 CARTON (16864-040-02) / 56.7 g in 1 TUBEMarketed from Sep 1, 2021 |
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)
- Triple Antifungal
- Generic name (nonproprietary)
- miconazole nitrate
- Active ingredients
- Miconazole nitrate — 2 g/100g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- Advantice Health, LLCNDC labeler code 16864
- 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 16864-040_4d63f2a2-f113-d739-e063-6394a90a2d27SPL ID 4d63f2a2-f113-d739-e063-6394a90a2d27SPL set ID 9a47fb1b-a41f-4c8a-8e43-7332853c308eRxCUI 998442, 998460UNII 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
N416864004002followed by a unit qualifier and the quantityPackage 16864-0040-02. 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 For the treatment of superficial skin infections caused by yeast (Candida albicans) Relieves discomfort, irrit.ation, redness and chafing associated with jock itch Cures most jock itch (tinea cruris)
Excerpt only. Read the full label for complete information.
About NDC 16864-040
- What is NDC 16864-040?
- 16864-040 is the product NDC for Triple Antifungal (miconazole nitrate), Miconazole nitrate 2 g/100g ointment, listed with the FDA by Advantice Health, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Triple Antifungal (Miconazole Nitrate).
- What is the active ingredient?
- Miconazole nitrate.
- Who is the labeler?
- Advantice Health, LLC, NDC labeler code 16864. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Triple Antifungal?
- 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 |
|---|---|---|---|---|
| CVS Health Athletes Foottolnaftate | Tolnaftate 10 mg/g | CreamTopical | CVS Pharmacy, Inc. | 69842-336 |
| TINGOLE FUNGAL NAIL Patchestolnaftate 1% fungal nail patches | Tolnaftate 1 g/1001 | PatchTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-221 |
| Wish Hand Sanitizer Coconut Cream White Floralsalcohol hand sanitizer | Alcohol 70 mL/100mL | SprayTopical | PT SUPER HOME PRODUCT INDONESIA | 85537-108 |
| Dr CANUSO fungal nail erasertolnaftate oil | Tolnaftate .3 g/28g | OilTopical | Renu Laboratories, LLC | 76348-410 |
| cmojsk TOENAIL FUNGUS PENundecylenic acid 25% tolnaftate 1% toenail fungus pen | Tolnaftate 1 g/100mL; Undecylenic acid 25 g/100mL | LiquidTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-220 |
| Wish Hand Sanitizer Sweet Guava Fresh Coconutalcohol hand sanitizer | Alcohol 70 mL/100mL | SprayTopical | PT SUPER HOME PRODUCT INDONESIA | 85537-106 |
| Wish Hand Sanitizer Dragonfruit Jasminealcohol hand sanitizer | Alcohol 70 mL/100mL | SprayTopical | PT SUPER HOME PRODUCT INDONESIA | 85537-107 |
| Hongo Killertolnaftate | Tolnaftate .1 g/10g | Aerosol, PowderTopical | Efficient Laboratories Inc | 58593-285 |
| Pedikleertolnaftate | Tolnaftate 1 g/100g | CreamTopical | Rising Pharma Holdings, Inc. | 57237-354 |
| Athletes Footmiconazole nitrate | Miconazole nitrate 20 mg/g | Aerosol, PowderTopical | Premier Brands of America Inc | 56104-912 |
| Tolnaftate | Tolnaftate 10 mg/g | CreamTopical | Sheffield Pharmaceuticals LLC | 11527-051 |
| THERA Antifungal Bodymiconazole nitrate | Miconazole nitrate 20 mg/g | PowderTopical | McKesson Medical-Surgical Inc. | 68599-0207 |
| LMNOOP MENS Private Health Creammens private health cream | Oatmeal 1 g/100g | CreamTopical | Shenzhen Ishan Technology Co., Ltd | 73076-210 |
| Hermon Jock Itch Ringworm Athletes Foot Creammiconazole nitrate | Miconazole nitrate 2 g/100g | CreamTopical | Beautivity LLC | 85398-036 |
| Antifungal Bodymiconazole nitrate | Miconazole nitrate 2 mg/100mL | CreamTopical | McKesson | 68599-0206 |
| LYSSERA Fungal Nail Renewalundecylenic acid 25% antifunga | Undecylenic acid 25 g/100mL | LiquidTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-174 |
| Anti-Fungal Powdermiconazole nitrate | Miconazole nitrate 20 mg/g | PowderTopical | The Kroger Co. | 30142-947 |
| Hydrocortisone 1%hydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | Chain Drug Marketing Association Inc. | 83324-329 |
| Antifungal Medicated Body Washtolnaftate | Tolnaftate 1 g/100g | GelTopical | Rida LLC | 83004-012 |
| Vamy ANTIFUNGALtolnaftate 1% antifungal | Tolnaftate 1 g/100mL | SprayTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-176 |
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