Over-the-counter drug · OTC MONOGRAPH DRUG
Vite20 (Miconazole nitrate) NDC 63347-810
Miconazole nitrate .3 mg/15mL · Liquid · Topical · Blaine Labs Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63347-810-01 | 6334708100163347081001 | 1 BOTTLE in 1 BOX (63347-810-01) / 15 mL in 1 BOTTLEMarketed from Apr 1, 2016 |
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)
- Vite20
- Generic name (nonproprietary)
- miconazole nitrate
- Active ingredients
- Miconazole nitrate — .3 mg/15mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- Blaine Labs Inc.NDC labeler code 63347
- 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 63347-810_27a77fc1-4426-4d60-822b-3d85a0560f13SPL ID 27a77fc1-4426-4d60-822b-3d85a0560f13SPL set ID 28a8d0dd-aab9-44ff-bab6-7ec4b5036a71RxCUI 998525UNII 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
N463347081001followed by a unit qualifier and the quantityPackage 63347-0810-01. 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)
INDICATIONS Cures most Athlete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris), and Ringworm (Tinea Corporis) Relieves Itching, cracking, burning and scaling. which accompany these conditions Prevents most Athlete's Foot with daily use
Excerpt only. Read the full label for complete information.
About NDC 63347-810
- What is NDC 63347-810?
- 63347-810 is the product NDC for Vite20 (miconazole nitrate), Miconazole nitrate .3 mg/15mL liquid, listed with the FDA by Blaine Labs Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vite20 (Miconazole nitrate).
- What is the active ingredient?
- Miconazole nitrate.
- Who is the labeler?
- Blaine Labs Inc., NDC labeler code 63347. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vite20?
- 1 other product NDC are listed under this name. See all Vite20 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Vite20 products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Vite20undecylenic acid | Undecylenic acid 2 mg/20mL | CreamTopical | Blaine Labs Inc. | 63347-800 | 63347-0800-01 |
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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