Over-the-counter drug · OTC MONOGRAPH DRUG
Povidone-Iodine Gel (Povidone-iodine) NDC 65517-0070
Povidone-iodine 1 g/100mL · Gel · Topical · Dukal LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65517-0070-1 | 6551700700165517007001 | 29.5 mL in 1 POUCH (65517-0070-1)Marketed from Jan 21, 2025 |
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)
- Povidone-Iodine Gel
- Generic name (nonproprietary)
- povidone-iodine
- Active ingredients
- Povidone-iodine — 1 g/100mL
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Dukal LLCNDC labeler code 65517
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 65517-0070_43f8fa10-9266-a4f3-e063-6394a90a9e93SPL ID 43f8fa10-9266-a4f3-e063-6394a90a9e93SPL set ID 2bebe082-59b6-17c1-e063-6294a90a9a52UNII 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
N465517007001followed by a unit qualifier and the quantityPackage 65517-0070-01. 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 Patient preoperative skin preparation. Helps to reduce bacteria that potentially can cause skin infection.
Excerpt only. Read the full label for complete information.
About NDC 65517-0070
- What is NDC 65517-0070?
- 65517-0070 is the product NDC for Povidone-Iodine Gel (povidone-iodine), Povidone-iodine 1 g/100mL gel, listed with the FDA by Dukal LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Povidone-Iodine Gel (Povidone-Iodine).
- What is the active ingredient?
- Povidone-iodine.
- Who is the labeler?
- Dukal LLC, NDC labeler code 65517. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Povidone-Iodine Gel?
- 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 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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