Over-the-counter drug · OTC MONOGRAPH DRUG
PVP-I Pouch foil-foil (povidone-iodine) NDC 65517-0035
Povidone-iodine 1 g/100mL · Solution · Topical · Dukal LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65517-0035-1 | 65517003501 | 500 POUCH in 1 CASE (65517-0035-1) / 22 mL in 1 POUCHMarketed from Jan 31, 2018 | |
| 65517-0035-2 | 65517003502 | 250 POUCH in 1 CASE (65517-0035-2) / 29.57 mL in 1 POUCHMarketed from Nov 9, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- PVP-I Pouch foil-foil
- Generic name (nonproprietary)
- povidone-iodine
- Active ingredients
- Povidone-iodine — 1 g/100mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Dukal LLC
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 65517-0035_43f8ee7b-b7fb-b4ce-e063-6294a90a2500SPL ID 43f8ee7b-b7fb-b4ce-e063-6294a90a2500SPL set ID 45aefabf-5283-411a-b509-749977635938RxCUI 312564UNII 85H0HZU99M
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
N465517003501followed by a unit qualifier and the quantityPackage 65517-0035-01. 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: For preparation prior to surgery. Helps to reduce bacteria that can potentially cause skin infection.
Excerpt only. Read the full label for complete information.
Other NDCs under 505G(a)(3)
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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| PURELL Hand Sanitizing Wipes Clean Refreshing Scentbenzalkonium chloride wipe | Benzalkonium chloride .13 mg/100mL | ClothTopical | GOJO Industries, Inc. | 21749-359 |
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| Safeguard Hand Sanitizeralcohol | Alcohol 64 g/100mL | GelTopical | The Procter & Gamble Manufacturing Company | 37000-603 |
| Hand Washbenzalkonium chloride | Benzalkonium chloride 1.3 mg/mL | LiquidTopical | Demoulas Super Markets, Inc | 53942-466 |
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| CVS Antisepticcetylpyridinium chloride | Cetylpyridinium chloride .7 mg/mL | RinseOral | CVS Pharmacy, Inc. | 59779-299 |
| Anti Bacterial Hand Gel Winteralcohol | Alcohol 71 mL/100mL | GelTopical | Bath & Body Works, Inc. | 62670-6957 |
| Anti Bacterial Hand Gel Black Cherry Merlotalcohol | Alcohol 71 mL/100mL | GelTopical | Bath & Body Works, Inc. | 62670-6693 |
| Antibacterial Foaming Skin Cleanserbenzalkonium chloride | Benzalkonium chloride .13 mg/mL | SoapTopical | Betco Corporation, Ltd. | 65601-709 |
| Hawthorn Hygiene Solutions ENERGY ANTIBACTERIAL FOAM FRAGRANCE FREE 1200 mLbenzalkonium chloride | Benzalkonium chloride .0013 mg/mL | LiquidTopical | BUNZL Distribution | 66294-114 |
| PRO-LINK Free Hands Antibacterial Foam So apchloroxylenol | Chloroxylenol .003 mg/mL | LiquidTopical | Pro-Link, Inc. | 66908-081 |
| B-Pure Moisturizing Hand Sanitizer with Collagen Sugared Iris Scentedalcohol | Alcohol 70 mL/100mL | LiquidTopical | Fourstar Group USA, Inc. | 80684-227 |
| Fresh Feels Hand Sanitizer Mist Seashell Sunshine Scentethyl alcohol | Alcohol 70 mL/100mL | SprayTopical | Amber Glow Cosmetics Limited | 87302-202 |
| Sparkling Cranberry Hand Sanitizeralcohol | Alcohol .62 mL/mL | GelTopical | Target Corporation | 11673-782 |
| Safeguard Antibacterial Foamingbenzalkonium chloride | Benzalkonium chloride .12 g/100mL | SoapTopical | The Procter & Gamble Manufacturing Company | 37000-601 |
| Advanced Hand Sanitizeralcohol | Alcohol 70 mL/100mL | GelTopical | Salado Sales Inc. | 57243-370 |
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