Over-the-counter drug · OTC MONOGRAPH DRUG
Povidone Iodine Impregnated (Povidone iodine) NDC 34645-1028
Povidone-iodine 7.5 mg/mL · Sponge · Topical · Jianerkang Medical Co., Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 34645-1028-1 | 3464510280134645102801 | 10 POUCH in 1 BOX (34645-1028-1) / 100 mL in 1 POUCHMarketed from Sep 10, 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 Impregnated
- Generic name (nonproprietary)
- povidone iodine
- Active ingredients
- Povidone-iodine — 7.5 mg/mL
- Dosage form
- Sponge
- 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 34645-1028_085cf04e-cf69-92d5-e063-6394a90a2d9aSPL ID 085cf04e-cf69-92d5-e063-6394a90a2d9aSPL set ID ccf3b4c4-2c33-4fae-9916-1149d40c7876UNII 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
N434645102801followed by a unit qualifier and the quantityPackage 34645-1028-01. 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 For preparation of skin and mucous membranes prior to surgery
Excerpt only. Read the full label for complete information.
About NDC 34645-1028
- What is NDC 34645-1028?
- 34645-1028 is the product NDC for Povidone Iodine Impregnated (povidone iodine), Povidone-iodine 7.5 mg/mL sponge, 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 Impregnated (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 Impregnated?
- 5 other product NDCs are listed under this name. See all Povidone Iodine Impregnated 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 Impregnated 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 Impregnatedpovidone iodine | Povidone-iodine .1 mg/mL | SpongeTopical | Jianerkang Medical Co., Ltd | 34645-1030 | 34645-1030-01 |
| Povidone Iodine Impregnatedpovidone iodine | Povidone-iodine 7.5 mg/mL | SpongeTopical | Jianerkang Medical Co., Ltd | 34645-1031 | 34645-1031-01 |
| Povidone Iodine Impregnatedpovidone iodine | Povidone-iodine 7.5 mg/mL | SpongeTopical | Jianerkang Medical Co., Ltd | 34645-1032 | 34645-1032-01 |
| Povidone Iodine Impregnatedpovidone iodine | Povidone-iodine 10 mg/mL | SpongeTopical | Jianerkang Medical Co., Ltd | 34645-4010 | 34645-4010-04 |
| Povidone Iodine Impregnatedpovidone iodine | Povidone-iodine 7.5 mg/mL | SpongeTopical | Jianerkang Medical Co., Ltd | 34645-4020 | 34645-4020-04 |
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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