Over-the-counter drug · OTC MONOGRAPH DRUG

Povidone-Iodine NDC 81280-003

Povidone-iodine .1 mg/mL · Swab · Topical · Mazza Healthcare, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)81280-003Labeler and product segments. Claims need a package NDC.
Product NDC at billing width81280-0003Add 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
81280-003-0181280000301500 POUCH in 1 CARTON (81280-003-01) / 1 APPLICATOR in 1 POUCH / 2.5 mL in 1 APPLICATORMarketed from Mar 1, 2021
81280-003-0381280000303500 POUCH in 1 CARTON (81280-003-03) / 3 APPLICATOR in 1 POUCH / 4.5 mL in 1 APPLICATORMarketed from Mar 1, 2021

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 005
Marketing start
Listing expires
Identifiers
Product ID 81280-003_58d9f789-b981-422e-8042-16dfeea07447SPL ID 58d9f789-b981-422e-8042-16dfeea07447SPL set ID 31df570a-35ae-41a2-b04a-fce65e9d596dRxCUI 1037205UNII 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

N481280000301 followed by a unit qualifier and the quantity

Package 81280-0003-01. 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.

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 Sea Salt Green Herbsalcohol hand sanitizerAlcohol 70 mL/100mLSprayTopicalPT SUPER HOME PRODUCT INDONESIA85537-206
Nail Renovar PlustolnaftateTolnaftate 1 g/100mLLiquidTopicalSOHM, Inc50405-030
Hongo KillertolnaftateMiconazole nitrate .2 g/10gAerosol, SprayTopicalEfficient Laboratories Inc58593-625
Miconazole Nitrateathletes foot liquidMiconazole nitrate 3 g/150gSprayTopicalWalgreens Company0363-4208
Fitcube NAIL REPAIR PENundecylenic acid 25% tolnaftate 1% nail repair penUndecylenic acid 25 g/100mL; Tolnaftate 1 g/100mLLiquidTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-230
WISH HAND SANITIZER Marshmallow Vanillaalcohol hand sanitizerAlcohol 70 mL/100mLSprayTopicalPT SUPER HOME PRODUCT INDONESIA85537-207
Recuren Plus Jock Itch Creammiconazole nitrate 2%Miconazole nitrate 20 mg/gCreamTopicalREGENEREN PLUS LTD87014-004
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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