Over-the-counter drug · OTC MONOGRAPH DRUG
Povidone-Iodine Topical Antiseptic (Povidone-iodine) NDC 53329-939
Povidone-iodine 10 mg/mL · Solution · Topical · Medline Industries, LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53329-939-04 | 5332909390453329093904 | 118 mL in 1 BOTTLE, PLASTIC (53329-939-04)Marketed from Oct 27, 2017 | |
| 53329-939-06 | 5332909390653329093906 | 473 mL in 1 BOTTLE, PLASTIC (53329-939-06)Marketed from Jan 1, 2007 | |
| 53329-939-08 | 5332909390853329093908 | 237 mL in 1 BOTTLE, PLASTIC (53329-939-08)Marketed from Jan 1, 2007 | |
| 53329-939-13 | 5332909391353329093913 | 59 mL in 1 BOTTLE, PLASTIC (53329-939-13)Marketed from Jan 1, 2007 | |
| 53329-939-23 | 5332909392353329093923 | 946 mL in 1 BOTTLE, PLASTIC (53329-939-23)Marketed from Jan 1, 2007 | |
| 53329-939-25 | 5332909392553329093925 | 3785 mL in 1 BOTTLE, PLASTIC (53329-939-25)Marketed from Jan 1, 2007 | |
| 53329-939-69 | 5332909396953329093969 | 88 mL in 1 BOTTLE, PLASTIC (53329-939-69)Marketed from Jan 1, 2007 |
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)
- Povidone-Iodine Topical AntisepticSuffix: Topical Antiseptic
- Generic name (nonproprietary)
- povidone-iodine
- Active ingredients
- Povidone-iodine — 10 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Medline Industries, LPNDC labeler code 53329
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 53329-939_5a2041f7-ae03-0415-e063-6394a90acc4fSPL ID 5a2041f7-ae03-0415-e063-6394a90acc4fSPL set ID c9036a83-22f5-4a09-b01c-7093d4192c19RxCUI 312564UNII 85H0HZU99MUPC 0080196732237
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
N453329093904followed by a unit qualifier and the quantityPackage 53329-0939-04. 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 single use when used for patient preoperative skin preparation
Excerpt only. Read the full label for complete information.
About NDC 53329-939
- What is NDC 53329-939?
- 53329-939 is the product NDC for Povidone-Iodine Topical Antiseptic, Povidone-iodine 10 mg/mL solution, listed with the FDA by Medline Industries, LP. It has 7 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Povidone-Iodine Topical Antiseptic (Povidone-Iodine).
- What is the active ingredient?
- Povidone-iodine.
- Who is the labeler?
- Medline Industries, LP, NDC labeler code 53329. 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 Topical Antiseptic?
- 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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