Over-the-counter drug · OTC MONOGRAPH DRUG
Povidone Iodine Prep (Povidone-iodine) NDC 34645-5506
Povidone-iodine 100 mg/g · Swab · Topical · Jianerkang Medical Co., Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 34645-5506-0 | 3464555060034645550600 | 500 POUCH in 1 CARTON (34645-5506-0) / 1 POUCH in 1 POUCH / 2.5 g in 1 POUCHMarketed from Aug 1, 2019 | |
| 34645-5506-1 | 3464555060134645550601 | 250 POUCH in 1 CARTON (34645-5506-1) / 3 POUCH in 1 POUCH / 13.5 g in 1 POUCHMarketed from Aug 1, 2019 |
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
- Generic name (nonproprietary)
- povidone-iodine
- Active ingredients
- Povidone-iodine — 100 mg/g
- Dosage form
- Swab
- 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 34645-5506_21da7d31-19ce-a5cb-e063-6294a90a63a4SPL ID 21da7d31-19ce-a5cb-e063-6294a90a63a4SPL set ID c1862529-e8d8-4440-a043-38c01079ee8aRxCUI 797730UNII 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
N434645550600followed by a unit qualifier and the quantityPackage 34645-5506-00. 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 Health-care antiseptic for preparation of the skin prior to surgery First aid antiseptic to help prevent the risk of skin infection in minor cuts,scrapes,and burns.
Excerpt only. Read the full label for complete information.
About NDC 34645-5506
- What is NDC 34645-5506?
- 34645-5506 is the product NDC for Povidone Iodine Prep (povidone-iodine), Povidone-iodine 100 mg/g swab, listed with the FDA by Jianerkang Medical Co., Ltd. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Povidone Iodine Prep (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?
- 7 other product NDCs are listed under this name. See all Povidone Iodine Prep NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Povidone Iodine Prep products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Povidone Iodine Preppovidone iodine | Povidone-iodine 10 g/100mL | SolutionTopical | Sion Biotext Medical Ltd | 68786-010 | 68786-0010-0868786-0010-89 |
| Povidone-Iodine Preppovidone-iodine | Povidone-iodine 100 mg/mL | SolutionTopical | O&M HALYARD, INC. | 39892-0809 | 39892-0809-01 |
| Povidone Iodine Preppovidone-iodine | Povidone-iodine 7.5 g/100g | SolutionTopical | Jianerkang Medical Co., Ltd | 34645-5501 | 34645-5501-00 |
| Povidone Iodine Preppovidone-iodine | Povidone-iodine 10 g/100g | SolutionTopical | Jianerkang Medical Co., Ltd | 34645-5503 | 34645-5503-00 |
| Povidone Iodine Preppovidone-iodine | Povidone-iodine 10 g/100g | SolutionTopical | Jianerkang Medical Co., Ltd | 34645-5504 | 34645-5504-00 |
| Povidone Iodine Preppovidone iodine | Povidone-iodine 1 g/100mL | SolutionTopical | Sion Biotext Medical Ltd | 68786-132 | 68786-0132-0168786-0132-02 |
| Povidone Iodine Preppovidone iodine | Povidone-iodine 1 g/100mL | SwabTopical | PHOENIX HEALTHCARE SOLUTIONS, LLC | 60913-999 | 60913-0999-02 |
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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