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 | 6551700350165517003501 | 500 POUCH in 1 CASE (65517-0035-1) / 22 mL in 1 POUCHMarketed from Jan 31, 2018 | |
| 65517-0035-2 | 6551700350265517003502 | 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 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 65517-0035_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.
About NDC 65517-0035
- What is NDC 65517-0035?
- 65517-0035 is the product NDC for PVP-I Pouch foil-foil (povidone-iodine), Povidone-iodine 1 g/100mL solution, listed with the FDA by Dukal LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- PVP-I Pouch foil-foil (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 PVP-I Pouch foil-foil?
- 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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