Over-the-counter drug · OTC MONOGRAPH DRUG
Miconazole Nitrate NDC 84387-003
Miconazole nitrate 20 mg/g · Ointment · Topical · ALLIED TRADE LINK LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84387-003-01 | 8438700030184387000301 | 28.4 g in 1 TUBE (84387-003-01)Marketed from Oct 25, 2024 |
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)
- Miconazole Nitrate
- Generic name (nonproprietary)
- miconazole nitrate
- Active ingredients
- Miconazole nitrate — 20 mg/g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- ALLIED TRADE LINK LLCNDC labeler code 84387
- 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 84387-003_26bc78a5-3755-5f69-e063-6394a90a11a8SPL ID 26bc78a5-3755-5f69-e063-6394a90a11a8SPL set ID 25520dba-0159-2a3f-e063-6294a90a4c33UNII 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
N484387000301followed by a unit qualifier and the quantityPackage 84387-0003-01. 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)
DIRECTIONS AND USES Uses For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet Clean the affected area and dry thoroughly Apply a thin layer of the cream over affected area twice daily (morning and night) or as directed by a doctor Supervise children in the use of this product For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily For athlete's foot and ringworm, use daily for 4 weeks For jock itch, use daily for 2 weeks If condition p…
Excerpt only. Read the full label for complete information.
About NDC 84387-003
- What is NDC 84387-003?
- 84387-003 is the product NDC for Miconazole Nitrate, Miconazole nitrate 20 mg/g ointment, listed with the FDA by ALLIED TRADE LINK LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Miconazole Nitrate.
- What is the active ingredient?
- Miconazole nitrate.
- Who is the labeler?
- ALLIED TRADE LINK LLC, NDC labeler code 84387. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Miconazole Nitrate?
- 43 other product NDCs are listed under this name. See all Miconazole Nitrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Miconazole Nitrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Miconazole Nitrateantifungal powder spray | Miconazole nitrate 20 mg/g | Aerosol, PowderTopical | Premier Brands of America Inc. | 56104-907 | 56104-0907-01 |
| Miconazole nitrateantifungal miconazole liquid continuous spray | Miconazole nitrate 20 mg/g | Aerosol, SprayTopical | Premier Brands of America Inc. | 56104-903 | 56104-0903-01 |
| Miconazole Nitrateanti-fungal powder miconazole nitrate talc free | Miconazole nitrate 20 mg/g | PowderTopical | Discount Drug Mart, Inc | 53943-976 | 53943-0976-01 |
| Miconazole Nitrateanti-fungal powder miconazole nitrate talc free | Miconazole nitrate 20 mg/g | PowderTopical | Hudson Health LLC | 72446-014 | 72446-0014-01 |
| Miconazole Nitrateathletes foot powder spray talc free | Miconazole nitrate 20 mg/g | Aerosol, PowderTopical | Chain Drug Marketing Association | 83324-233 | 83324-0233-46 |
| Miconazole Nitrate | Miconazole nitrate 2 g/100g | PowderTopical | AvKARE | 42291-938 | 42291-0938-85 |
| Miconazole Nitrate | Miconazole nitrate 20 mg/g | CreamTopical | STRATEGIC SOURCING SERVICES LLC | 70677-1000 | 70677-1000-01 |
| miconazole nitrate | Miconazole nitrate 20 mg/mL | SolutionTopical | AvPAK | 50268-503 | 50268-0503-29 |
| Miconazole Nitrateantifungal miconazole powder spray | Miconazole nitrate 2.6 g/130g | Aerosol, SprayTopical | Premier Brands of America Inc. | 56104-121 | 56104-0121-01 |
| Miconazole Nitrateantifungal miconazole powder spray | Miconazole nitrate 2.6 g/130g | Aerosol, SprayTopical | Walgreens Company | 0363-7418 | 00363-7418-00 |
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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