Over-the-counter drug · OTC MONOGRAPH DRUG

Povidone Iodine Impregnated (povidone iodine) NDC 34645-4010

Povidone-iodine 10 mg/mL · Sponge · Topical · Jianerkang Medical Co., Ltd

NDC codes

FDA NDC Directory
Product NDC (as listed)34645-4010Labeler and product segments. Claims need a package NDC.
Product NDC at billing width34645-4010Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
34645-4010-434645401004100 mL in 1 POUCH (34645-4010-4)Marketed from Jan 1, 2010

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 — 10 mg/mL
Dosage form
Sponge
Route
Topical
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 005
Marketing start
Listing expires
Identifiers
Product ID 34645-4010_085ba045-3c6d-fb30-e063-6394a90a3491SPL ID 085ba045-3c6d-fb30-e063-6394a90a3491SPL set ID 14f2a1dd-92c2-49e8-9fa0-a9d88e8c530dUNII 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

N434645401004 followed by a unit qualifier and the quantity

Package 34645-4010-04. 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 For preparation of skin and mucous membranes prior to surgery

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under M 005

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 005
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WISH HAND SANITIZER Marshmallow Vanillaalcohol hand sanitizerAlcohol 70 mL/100mLSprayTopicalPT SUPER HOME PRODUCT INDONESIA85537-207
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Lightning X Hand Cleanserethyl alcoholAlcohol 62 mL/100mLGelTopicalNantong Health & Beyond Hygienic Products Inc.43473-122
Tolnaftatemeijer athletes foot liquid sprayTolnaftate 1.5 g/150gAerosol, SprayTopicalMeijer Distribution Inc.79481-0591

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