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| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81280-003-01 | 8128000030181280000301 | 500 POUCH in 1 CARTON (81280-003-01) / 1 APPLICATOR in 1 POUCH / 2.5 mL in 1 APPLICATORMarketed from Mar 1, 2021 | |
| 81280-003-03 | 8128000030381280000303 | 500 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
- Labeler
- Mazza Healthcare, LLCNDC labeler code 81280
- 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
N481280000301followed by a unit qualifier and the quantityPackage 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.
About NDC 81280-003
- What is NDC 81280-003?
- 81280-003 is the product NDC for Povidone-Iodine, Povidone-iodine .1 mg/mL swab, listed with the FDA by Mazza Healthcare, LLC. It has 2 package NDCs, 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?
- Mazza Healthcare, LLC, NDC labeler code 81280. 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.
Related NDCs: other Povidone-Iodine 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 | Povidone-iodine 100 mg/mL | SolutionTopical | Major Pharmaceuticals | 0904-7639 | 00904-7639-54 |
| Povidone-Iodine | Povidone-iodine 10 mg/mL | SolutionTopical | H E B | 37808-624 | 37808-0624-34 |
| Povidone-Iodine | Povidone-iodine 100 mg/mL | SolutionTopical | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0757 | 70000-0757-01 |
| Povidone-Iodine | Povidone-iodine 10 mg/mL | SolutionTopical | Acme United Corporation | 0924-5408 | 00924-5408-0100924-5408-02 |
| Povidone Iodinepovidone-iodine | Povidone-iodine .1 g/1 | SwabTopical | TwinMed LLC | 55681-752 | 55681-0752-00 |
| Povidone Iodinepovidone-iodine | Povidone-iodine .1 g/1 | SwabTopical | TwinMed LLC | 55681-753 | 55681-0753-00 |
| Povidone Iodinepovidone-iodine | Povidone-iodine .1 g/g | SwabTopical | TwinMed LLC | 55681-751 | 55681-0751-00 |
| Povidone Iodinepovidone iodine 10% | Povidone-iodine 100 mg/g | OintmentTopical | Trifecta Pharmaceuticals USA LLC | 69396-112 | 69396-0112-20 |
| Povidone Iodinepovidone-iodine | Povidone-iodine 100 mg/g | OintmentTopical | Dr Radows | 81584-1102 | 81584-1102-01 |
| Povidone-Iodine | Povidone-iodine .1 mg/mL | SwabTopical | Mazza Healthcare, LLC | 81280-002 | 81280-0002-01 |
Other NDCs under M 005
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| CVS Health Athletes Foottolnaftate | Tolnaftate 10 mg/g | CreamTopical | CVS Pharmacy, Inc. | 69842-336 |
| TINGOLE FUNGAL NAIL Patchestolnaftate 1% fungal nail patches | Tolnaftate 1 g/1001 | PatchTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-221 |
| Wish Hand Sanitizer Coconut Cream White Floralsalcohol hand sanitizer | Alcohol 70 mL/100mL | SprayTopical | PT SUPER HOME PRODUCT INDONESIA | 85537-108 |
| Dr CANUSO fungal nail erasertolnaftate oil | Tolnaftate .3 g/28g | OilTopical | Renu Laboratories, LLC | 76348-410 |
| cmojsk TOENAIL FUNGUS PENundecylenic acid 25% tolnaftate 1% toenail fungus pen | Tolnaftate 1 g/100mL; Undecylenic acid 25 g/100mL | LiquidTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-220 |
| Wish Hand Sanitizer Sweet Guava Fresh Coconutalcohol hand sanitizer | Alcohol 70 mL/100mL | SprayTopical | PT SUPER HOME PRODUCT INDONESIA | 85537-106 |
| Wish Hand Sanitizer Dragonfruit Jasminealcohol hand sanitizer | Alcohol 70 mL/100mL | SprayTopical | PT SUPER HOME PRODUCT INDONESIA | 85537-107 |
| Hongo Killertolnaftate | Tolnaftate .1 g/10g | Aerosol, PowderTopical | Efficient Laboratories Inc | 58593-285 |
| Pedikleertolnaftate | Tolnaftate 1 g/100g | CreamTopical | Rising Pharma Holdings, Inc. | 57237-354 |
| Athletes Footmiconazole nitrate | Miconazole nitrate 20 mg/g | Aerosol, PowderTopical | Premier Brands of America Inc | 56104-912 |
| Tolnaftate | Tolnaftate 10 mg/g | CreamTopical | Sheffield Pharmaceuticals LLC | 11527-051 |
| THERA Antifungal Bodymiconazole nitrate | Miconazole nitrate 20 mg/g | PowderTopical | McKesson Medical-Surgical Inc. | 68599-0207 |
| LMNOOP MENS Private Health Creammens private health cream | Oatmeal 1 g/100g | CreamTopical | Shenzhen Ishan Technology Co., Ltd | 73076-210 |
| Hermon Jock Itch Ringworm Athletes Foot Creammiconazole nitrate | Miconazole nitrate 2 g/100g | CreamTopical | Beautivity LLC | 85398-036 |
| Antifungal Bodymiconazole nitrate | Miconazole nitrate 2 mg/100mL | CreamTopical | McKesson | 68599-0206 |
| LYSSERA Fungal Nail Renewalundecylenic acid 25% antifunga | Undecylenic acid 25 g/100mL | LiquidTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-174 |
| Anti-Fungal Powdermiconazole nitrate | Miconazole nitrate 20 mg/g | PowderTopical | The Kroger Co. | 30142-947 |
| Hydrocortisone 1%hydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | Chain Drug Marketing Association Inc. | 83324-329 |
| Antifungal Medicated Body Washtolnaftate | Tolnaftate 1 g/100g | GelTopical | Rida LLC | 83004-012 |
| Vamy ANTIFUNGALtolnaftate 1% antifungal | Tolnaftate 1 g/100mL | SprayTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-176 |
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