Over-the-counter drug · OTC MONOGRAPH DRUG
Povidone Iodine NDC 34645-1043
Povidone-iodine .1 mg/mL · Swab · Topical · Jianerkang Medical Co., Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 34645-1043-1 | 3464510430134645104301 | 1 APPLICATOR in 1 POUCH (34645-1043-1) / 21 mL in 1 APPLICATORMarketed from Jun 11, 2015 |
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
- Generic name (nonproprietary)
- povidone iodine
- Active ingredients
- Povidone-iodine — .1 mg/mL
- 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 34645-1043_085e7fe4-e6a2-9dd9-e063-6294a90a9d87SPL ID 085e7fe4-e6a2-9dd9-e063-6294a90a9d87SPL set ID bbe0d44d-8752-44e6-acad-f8deeebdbf17UNII 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
N434645104301followed by a unit qualifier and the quantityPackage 34645-1043-01. 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)
Uses 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 34645-1043
- What is NDC 34645-1043?
- 34645-1043 is the product NDC for Povidone Iodine, Povidone-iodine .1 mg/mL swab, 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.
- 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?
- 28 other product NDCs are listed under this name. See all Povidone Iodine 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 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 | Povidone-iodine 100 mg/mL | SolutionTopical | Major Pharmaceuticals | 0904-7639 | 00904-7639-54 |
| Povidone-Iodine | Povidone-iodine 10 mg/mL | SolutionTopical | H E B | 37808-624 | 37808-0624-34 |
| Povidone-Iodine | Povidone-iodine 100 mg/mL | SolutionTopical | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0757 | 70000-0757-01 |
| Povidone-Iodine | Povidone-iodine 10 mg/mL | SolutionTopical | Acme United Corporation | 0924-5408 | 00924-5408-0100924-5408-02 |
| Povidone Iodinepovidone-iodine | Povidone-iodine .1 g/1 | SwabTopical | TwinMed LLC | 55681-752 | 55681-0752-00 |
| Povidone Iodinepovidone-iodine | Povidone-iodine .1 g/1 | SwabTopical | TwinMed LLC | 55681-753 | 55681-0753-00 |
| Povidone Iodinepovidone-iodine | Povidone-iodine .1 g/g | SwabTopical | TwinMed LLC | 55681-751 | 55681-0751-00 |
| Povidone Iodinepovidone iodine 10% | Povidone-iodine 100 mg/g | OintmentTopical | Trifecta Pharmaceuticals USA LLC | 69396-112 | 69396-0112-20 |
| Povidone Iodinepovidone-iodine | Povidone-iodine 100 mg/g | OintmentTopical | Dr Radows | 81584-1102 | 81584-1102-01 |
| Povidone-Iodine | Povidone-iodine .1 mg/mL | SwabTopical | Mazza Healthcare, LLC | 81280-002 | 81280-0002-01 |
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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