Over-the-counter drug · OTC MONOGRAPH DRUG
Saninta 10% Povidone-Iodine (Povidone-iodine solution) NDC 81351-004
Povidone-iodine 100 mg/mL · Liquid · Topical · LL Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81351-004-01 | 8135100040181351000401 | 3 APPLICATOR in 1 POUCH (81351-004-01) / 2.3 mL in 1 APPLICATORMarketed from Aug 25, 2021 | |
| 81351-004-02 | 8135100040281351000402 | 22.5 mL in 1 PACKET (81351-004-02)Marketed from Aug 25, 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)
- Saninta 10% Povidone-Iodine
- Generic name (nonproprietary)
- povidone-iodine solution
- Active ingredients
- Povidone-iodine — 100 mg/mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- LL PharmaNDC labeler code 81351
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Marketing end
- Identifiers
- Product ID 81351-004_47446355-315f-6485-e063-6294a90a0377SPL ID 47446355-315f-6485-e063-6294a90a0377SPL set ID bd344007-895e-30d6-e053-2a95a90a019dUNII 85H0HZU99MUPC 0628634499061
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
N481351000401followed by a unit qualifier and the quantityPackage 81351-0004-01. 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)
Use Antiseptic skin preparation. Helps reduce bacteria that potentially can cause skin infection.
Excerpt only. Read the full label for complete information.
About NDC 81351-004
- What is NDC 81351-004?
- 81351-004 is the product NDC for Saninta 10% Povidone-Iodine (povidone-iodine solution), Povidone-iodine 100 mg/mL liquid, listed with the FDA by LL Pharma. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Saninta 10% Povidone-Iodine (Povidone-Iodine Solution).
- What is the active ingredient?
- Povidone-iodine.
- Who is the labeler?
- LL Pharma, NDC labeler code 81351. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Saninta 10% Povidone-Iodine?
- 1 other product NDC are listed under this name. See all Saninta 10% 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 Saninta 10% 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) |
|---|---|---|---|---|---|
| Saninta 10% Povidone-Iodinepovidone-iodine solution | Povidone-iodine 100 mg/mL | LiquidTopical | Lernapharm | 68356-601 | 68356-0601-0168356-0601-0268356-0601-03 |
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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