Over-the-counter drug · OTC MONOGRAPH DRUG
Povidone-Iodine NDC 53329-938
Povidone-iodine .75 g/100mL · Solution · Topical · Medline Industries, LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53329-938-04 | 5332909380453329093804 | 118 mL in 1 BOTTLE (53329-938-04)Marketed from Apr 6, 2017 | |
| 53329-938-06 | 5332909380653329093806 | 473 mL in 1 BOTTLE (53329-938-06)Marketed from Apr 6, 2017 | |
| 53329-938-08 | 5332909380853329093808 | 237 mL in 1 BOTTLE (53329-938-08)Marketed from Apr 6, 2017 | |
| 53329-938-23 | 5332909382353329093823 | 946 mL in 1 BOTTLE (53329-938-23)Marketed from Apr 6, 2017 | |
| 53329-938-25 | 5332909382553329093825 | 3785 mL in 1 BOTTLE (53329-938-25)Marketed from Apr 6, 2017 |
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 — .75 g/100mL
- Dosage form
- Solution
- 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 53329-938_41c65656-ff98-67e5-e063-6394a90a6079SPL ID 41c65656-ff98-67e5-e063-6394a90a6079SPL set ID 2b95078e-2caf-7005-e054-00144ff88e88RxCUI 211747UNII 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
N453329093804followed by a unit qualifier and the quantityPackage 53329-0938-04. 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 the skin prior to surgery helps to reduce bacteria that potentially can cause skin infection significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care single use when used for patient preoperative skin preparation
Excerpt only. Read the full label for complete information.
About NDC 53329-938
- What is NDC 53329-938?
- 53329-938 is the product NDC for Povidone-Iodine, Povidone-iodine .75 g/100mL solution, listed with the FDA by Medline Industries, LP. It has 5 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?
- 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 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 505G(a)(3)
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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