Over-the-counter drug · OTC MONOGRAPH DRUG

Povidone Iodine NDC 34645-4009

Povidone-iodine 7.5 mg/mL · Solution · Topical · Jianerkang Medical Co., Ltd

NDC codes

FDA NDC Directory
Product NDC (as listed)34645-4009Labeler and product segments. Claims need a package NDC.
Product NDC at billing width34645-4009Add 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
34645-4009-63464540090634645400906109 mL in 1 BOTTLE, PLASTIC (34645-4009-6)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
Generic name (nonproprietary)
povidone iodine
Active ingredients
Povidone-iodine — 7.5 mg/mL
Dosage form
Solution
Route
Topical
Labeler
Jianerkang Medical Co., LtdNDC labeler code 34645
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 005
Marketing start
Listing expires
Identifiers
Product ID 34645-4009_085b3032-f1ad-4f71-e063-6294a90a1c05SPL ID 085b3032-f1ad-4f71-e063-6294a90a1c05SPL set ID e1789944-3a41-4c86-b173-3a6993ae2141RxCUI 314188UNII 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

N434645400906 followed by a unit qualifier and the quantity

Package 34645-4009-06. 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)

About NDC 34645-4009

What is NDC 34645-4009?
34645-4009 is the product NDC for Povidone Iodine, Povidone-iodine 7.5 mg/mL solution, 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.

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

Other Povidone Iodine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Povidone-IodinePovidone-iodine 100 mg/mLSolutionTopicalMajor Pharmaceuticals0904-763900904-7639-54
Povidone-IodinePovidone-iodine 10 mg/mLSolutionTopicalH E B37808-62437808-0624-34
Povidone-IodinePovidone-iodine 100 mg/mLSolutionTopicalCARDINAL HEALTH 110, LLC. DBA LEADER70000-075770000-0757-01
Povidone-IodinePovidone-iodine 10 mg/mLSolutionTopicalAcme United Corporation0924-540800924-5408-0100924-5408-02
Povidone Iodinepovidone-iodinePovidone-iodine .1 g/1SwabTopicalTwinMed LLC55681-75255681-0752-00
Povidone Iodinepovidone-iodinePovidone-iodine .1 g/1SwabTopicalTwinMed LLC55681-75355681-0753-00
Povidone Iodinepovidone-iodinePovidone-iodine .1 g/gSwabTopicalTwinMed LLC55681-75155681-0751-00
Povidone Iodinepovidone iodine 10%Povidone-iodine 100 mg/gOintmentTopicalTrifecta Pharmaceuticals USA LLC69396-11269396-0112-20
Povidone Iodinepovidone-iodinePovidone-iodine 100 mg/gOintmentTopicalDr Radows81584-110281584-1102-01
Povidone-IodinePovidone-iodine .1 mg/mLSwabTopicalMazza Healthcare, LLC81280-00281280-0002-01

All 29 Povidone Iodine NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
CVS Health Athletes FoottolnaftateTolnaftate 10 mg/gCreamTopicalCVS Pharmacy, Inc.69842-336
TINGOLE FUNGAL NAIL Patchestolnaftate 1% fungal nail patchesTolnaftate 1 g/1001PatchTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-221
Wish Hand Sanitizer Coconut Cream White Floralsalcohol hand sanitizerAlcohol 70 mL/100mLSprayTopicalPT SUPER HOME PRODUCT INDONESIA85537-108
Dr CANUSO fungal nail erasertolnaftate oilTolnaftate .3 g/28gOilTopicalRenu Laboratories, LLC76348-410
cmojsk TOENAIL FUNGUS PENundecylenic acid 25% tolnaftate 1% toenail fungus penTolnaftate 1 g/100mL; Undecylenic acid 25 g/100mLLiquidTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-220
Wish Hand Sanitizer Sweet Guava Fresh Coconutalcohol hand sanitizerAlcohol 70 mL/100mLSprayTopicalPT SUPER HOME PRODUCT INDONESIA85537-106
Wish Hand Sanitizer Dragonfruit Jasminealcohol hand sanitizerAlcohol 70 mL/100mLSprayTopicalPT SUPER HOME PRODUCT INDONESIA85537-107
Hongo KillertolnaftateTolnaftate .1 g/10gAerosol, PowderTopicalEfficient Laboratories Inc58593-285
PedikleertolnaftateTolnaftate 1 g/100gCreamTopicalRising Pharma Holdings, Inc.57237-354
Athletes Footmiconazole nitrateMiconazole nitrate 20 mg/gAerosol, PowderTopicalPremier Brands of America Inc56104-912
TolnaftateTolnaftate 10 mg/gCreamTopicalSheffield Pharmaceuticals LLC11527-051
THERA Antifungal Bodymiconazole nitrateMiconazole nitrate 20 mg/gPowderTopicalMcKesson Medical-Surgical Inc.68599-0207
LMNOOP MENS Private Health Creammens private health creamOatmeal 1 g/100gCreamTopicalShenzhen Ishan Technology Co., Ltd73076-210
Hermon Jock Itch Ringworm Athletes Foot Creammiconazole nitrateMiconazole nitrate 2 g/100gCreamTopicalBeautivity LLC85398-036
Antifungal Bodymiconazole nitrateMiconazole nitrate 2 mg/100mLCreamTopicalMcKesson68599-0206
LYSSERA Fungal Nail Renewalundecylenic acid 25% antifungaUndecylenic acid 25 g/100mLLiquidTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-174
Anti-Fungal Powdermiconazole nitrateMiconazole nitrate 20 mg/gPowderTopicalThe Kroger Co.30142-947
Hydrocortisone 1%hydrocortisoneHydrocortisone 1 g/100gCreamTopicalChain Drug Marketing Association Inc.83324-329
Antifungal Medicated Body WashtolnaftateTolnaftate 1 g/100gGelTopicalRida LLC83004-012
Vamy ANTIFUNGALtolnaftate 1% antifungalTolnaftate 1 g/100mLSprayTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-176

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