Over-the-counter drug · OTC MONOGRAPH DRUG

Medline (Povidone-iodine) NDC 53329-120

Povidone-iodine 10 mg/mL · Swab · Topical · Medline Industries, LP

NDC codes

FDA NDC Directory
Product NDC (as listed)53329-120Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53329-0120Add 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
53329-120-055332901200553329012005250 POUCH in 1 CASE (53329-120-05) / 1 APPLICATOR in 1 POUCH / 10 mL in 1 APPLICATORMarketed from Jul 1, 2024
53329-120-0953329012009533290120091 APPLICATOR in 1 POUCH (53329-120-09) / 10 mL in 1 APPLICATORMarketed from Jul 1, 2024
53329-120-2653329012026533290120264 POUCH in 1 BOX (53329-120-26) / 1 APPLICATOR in 1 POUCH / 10 mL in 1 APPLICATORMarketed from Jul 1, 2024

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)
Medline
Generic name (nonproprietary)
povidone-iodine
Active ingredients
Povidone-iodine — 10 mg/mL
Dosage form
Swab
Route
Topical
Labeler
Medline Industries, LPNDC labeler code 53329
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication 505G(a)(3)
Marketing start
Listing expires
Identifiers
Product ID 53329-120_1cea06a9-c416-d705-e063-6394a90a87efSPL ID 1cea06a9-c416-d705-e063-6394a90a87efSPL set ID 11fd1661-1b8c-b65b-e063-6394a90af89bRxCUI 1300277UNII 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

N453329012005 followed by a unit qualifier and the quantity

Package 53329-0120-05. 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 antiseptic skin preparation help reduce bacteria that potentially can cause skin infections

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53329-120

What is NDC 53329-120?
53329-120 is the product NDC for Medline (povidone-iodine), Povidone-iodine 10 mg/mL swab, listed with the FDA by Medline Industries, LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Medline (Povidone-iodine).
What is the active ingredient?
Povidone-iodine.
Who is the labeler?
Medline Industries, LP, NDC labeler code 53329. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Medline?
46 other product NDCs are listed under this name. See all Medline NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Medline NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MedlineacetaminophenAcetaminophen 325 mg/1TabletOralMedline Industries, LP53329-19953329-0199-09
MedlineacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMedline Industries, LP53329-22153329-0221-09
MedlineiburprofenIbuprofen 200 mg/1Tablet, Film coatedOralMedline Industries, LP53329-60353329-0603-09
MedlineacetaminophenAcetaminophen 500 mg/1TabletOralMedline Industries, LP53329-60553329-0605-09
Medlinemiconazole nitrateMiconazole nitrate 20 mg/gOintmentTopicalMedline Industries, LP53329-25653329-0256-1453329-0256-64
MedlineacetaminophenAcetaminophen 500 mg/1TabletOralMedline Industries, LP53329-60453329-0604-30
MedlinedimethiconeDimethicone 1.575 g/100mLCreamTopicalMedline Industries, LP53329-27153329-0271-4453329-0271-86
MedlineaspirinAspirin 81 mg/1Tablet, Delayed releaseOralMedline Industries, LP53329-60053329-0600-67
Medlinewhite petrolatumWhite petrolatum 86.5 g/100gOintmentTopicalMedline Industries, LP53329-25753329-0257-1053329-0257-74
Medlinezinc oxideZinc oxide 200 mg/gPasteTopicalMedline Industries, LP53329-25553329-0255-0553329-0255-10

All 47 Medline NDCs

Other NDCs under 505G(a)(3)

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

FDA NDC Directory listings under 505G(a)(3)
ProductStrengthForm · routeLabelerProduct NDC
Bcbgeneration 2 Pc Hand Sanitizer Mist - Mango And Strawberry Scentethyl alcohol—KitDiamond Life Cosmetics Trading FZCO87247-927
Touchland Power Mist Hand Sanitizer Lemon Lime SpritzalcoholAlcohol .7 mL/mLSprayTopicalChurch & Dwight Co., Inc.10237-106
Touchland Power Mist Hydrating Hand Sanitizer Mango PassionalcoholAlcohol 70 mL/100mLSprayTopicalChurch & Dwight Co., Inc.10237-130
tazza JIM WIPESbenzalkonium chlorideBenzalkonium chloride .13 g/100gClothTopicalTazza Brands East, Inc.76370-0039
Bee Clean - Beeswax Hand Sanitizer - Citrus and PeppermintalcoholAlcohol 70 mL/100mLSprayTopicalBeeCleanSpot81404-001
NatureWell Hydrating Hand Sanitizer Vanilla DaydreamalcoholAlcohol 70 mL/100mLLiquidTopicalAmerican Exchange Group78870-012
Senexon-Sdocusate sodium 50mg and sennosides 8.6mgSennosides 8.6 mg/1; Docusate sodium 50 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8331
B Pure Moisturizing Hand Sanitizer Dragon Fruit Bloom ScentedalcoholAlcohol 70 mL/100mLLiquidTopicalFourstar Group USA, Inc.80684-199
Coolkesi Biotin ConditionerconditionerAllium cepa whole .008 g/100mL + 5 more ingredientsPasteTopicalGuangdong Bisutang Biotechnology Co., LTD84753-042
enMotion Antimicrobial with Moisturizers, Tranquil Aloebenzalkonium chlorideBenzalkonium chloride 1.3 mg/mLSoapTopicalGeorgia-Pacific Consumer Products LP54622-700
CleanBoss Hand SanitizeralcoholAlcohol 76 mL/100mLGelTopicalInnovative Biodefense, Inc57362-523
Anti Bacterial Hand Gel Pink Peach BlossomalcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-6656
Anti Bacterial Hand Gel Twisted PeppermintalcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-6935
WhiskCare 387benzalkonium chlorideBenzalkonium chloride 1 mg/mLSolutionTopicalWhisk Products, Inc.65585-531
Hand Sanitizerethyl alcoholAlcohol 70 mL/100mLGelTopicalBiocosmetica Excel Argentina67623-002
Free and Pure Allergy Relief Dye Freediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralWALGREEN COMPANY0363-1175
Chemstation HACCP Q E2benzalkonium chlorideBenzalkonium chloride 1.2 g/LLiquidTopicalChemStation71212-101
Antibacterial Hand SanitizeralcoholAlcohol 620 mg/mLSprayTopicalTEKWELD SOLUTIONS, INC.71160-189
VQ Hydrating Hand Sanitizer Spiced PumpkinalcoholAlcohol 70 mL/100mLLiquidTopicalTychea Co.85980-014
Bcbgeneration 4 Pc Hand Sanitizers - Cherry Blossom, Brown Sugar Vanilla, Velvet Peach And Ocean Breeze Scentethyl alcohol—KitDiamond Life Cosmetics Trading FZCO87247-590

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