Over-the-counter drug · OTC MONOGRAPH DRUG
Prep Solution Topical Antiseptic Microbicide (Povidone-iodine) NDC 67326-350
Povidone-iodine 100 mg/mL · Solution · Topical · Degasa SA De CV
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67326-350-04 | 6732603500467326035004 | 948 mL in 1 BOTTLE (67326-350-04)Marketed from Jan 1, 2007 | |
| 67326-350-05 | 6732603500567326035005 | 59 mL in 1 BOTTLE (67326-350-05)Marketed from Mar 14, 2011 | |
| 67326-350-06 | 6732603500667326035006 | 118 mL in 1 BOTTLE (67326-350-06)Marketed from Jan 1, 2007 | |
| 67326-350-07 | 6732603500767326035007 | 237 mL in 1 BOTTLE (67326-350-07)Marketed from Jan 1, 2007 | |
| 67326-350-08 | 6732603500867326035008 | 474 mL in 1 BOTTLE (67326-350-08)Marketed from Jan 1, 2007 | |
| 67326-350-09 | 6732603500967326035009 | 3785 mL in 1 JUG (67326-350-09)Marketed from Jan 1, 2007 | |
| 67326-350-10 | 6732603501067326035010 | 89 mL in 1 BOTTLE (67326-350-10)Marketed from Nov 17, 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)
- Prep Solution Topical Antiseptic MicrobicideSuffix: Topical Antiseptic Microbicide
- Generic name (nonproprietary)
- povidone-iodine
- Active ingredients
- Povidone-iodine — 100 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Degasa SA De CVNDC labeler code 67326
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 67326-350_097358e0-eaba-c991-e063-6294a90acb81SPL ID 097358e0-eaba-c991-e063-6294a90acb81SPL set ID dd34cc57-8a8c-4189-b517-61448f961c9eRxCUI 312564UNII 85H0HZU99MUPC 7501048350810
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
N467326035004followed by a unit qualifier and the quantityPackage 67326-0350-04. 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)
Uses Healthcare antiseptic for preparation of the skin prior to surgery. First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.
Excerpt only. Read the full label for complete information.
About NDC 67326-350
- What is NDC 67326-350?
- 67326-350 is the product NDC for Prep Solution Topical Antiseptic Microbicide, Povidone-iodine 100 mg/mL solution, listed with the FDA by Degasa SA De CV. It has 7 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Prep Solution Topical Antiseptic Microbicide (Povidone-iodine).
- What is the active ingredient?
- Povidone-iodine.
- Who is the labeler?
- Degasa SA De CV, NDC labeler code 67326. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Prep Solution Topical Antiseptic Microbicide?
- 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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