Over-the-counter drug · OTC MONOGRAPH DRUG
Povidone Iodine Prep Solution Sterile (Povidone-iodine) NDC 34645-0013
Povidone-iodine 100 mg/mL · Solution · Topical · Jianerkang Medical Co., Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 34645-0013-1 | 3464500130134645001301 | 30 mL in 1 POUCH (34645-0013-1)Marketed from Jan 1, 2021 |
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 Prep Solution Sterile
- Generic name (nonproprietary)
- povidone-iodine
- Active ingredients
- Povidone-iodine — 100 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Jianerkang Medical Co., LtdNDC labeler code 34645
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 34645-0013_085d0195-7031-e123-e063-6294a90ab344SPL ID 085d0195-7031-e123-e063-6294a90ab344SPL set ID 95f8489e-05fa-4f0f-acd6-0c426009080eRxCUI 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
N434645001301followed by a unit qualifier and the quantityPackage 34645-0013-01. 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 Antiseptic skin preparation
Excerpt only. Read the full label for complete information.
About NDC 34645-0013
- What is NDC 34645-0013?
- 34645-0013 is the product NDC for Povidone Iodine Prep Solution Sterile, Povidone-iodine 100 mg/mL solution, listed with the FDA by Jianerkang Medical Co., Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Povidone Iodine Prep Solution Sterile (Povidone-iodine).
- What is the active ingredient?
- Povidone-iodine.
- Who is the labeler?
- Jianerkang Medical Co., Ltd, NDC labeler code 34645. 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 Prep Solution Sterile?
- 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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