Over-the-counter drug · NDA
Prevantics Maxi Swabstick NDC 10819-4076
chlorhexidine gluconate and isopropyl alcohol · Chlorhexidine gluconate 31.5 mg/mL; Isopropyl alcohol .7 mL/mL · Solution · Topical · Professional Disposables International, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10819-4076-3 | 1081940760310819407603 | 300 POUCH in 1 CASE (10819-4076-3) / 5.1 mL in 1 POUCHMarketed from Sep 1, 2023 | |
| 10819-4076-4 | 1081940760410819407604 | 30 POUCH in 1 BOX (10819-4076-4) / 5.1 mL in 1 POUCHMarketed from Dec 1, 2023 |
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)
- Prevantics Maxi Swabstick
- Generic name (nonproprietary)
- chlorhexidine gluconate and isopropyl alcohol
- Active ingredients
- Chlorhexidine gluconate — 31.5 mg/mLIsopropyl alcohol — .7 mL/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Professional Disposables International, Inc.NDC labeler code 10819
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021524
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 10819-4076_f5aff4be-ddc9-63ad-e053-2a95a90a426bSPL ID f5aff4be-ddc9-63ad-e053-2a95a90a426bSPL set ID 93ca3c07-40b4-3a91-e053-2995a90a0afdRxCUI 1191171, 1366736UNII MOR84MUD8E, ND2M416302
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
N410819407603followed by a unit qualifier and the quantityPackage 10819-4076-03. 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 for the preparation of the patient's skin prior to surgery or injection
Excerpt only. Read the full label for complete information.
About NDC 10819-4076
- What is NDC 10819-4076?
- 10819-4076 is the product NDC for Prevantics Maxi Swabstick, Chlorhexidine gluconate 31.5 mg/mL; Isopropyl alcohol .7 mL/mL solution, listed with the FDA by Professional Disposables International, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Prevantics Maxi Swabstick (Chlorhexidine gluconate and isopropyl alcohol).
- What is the active ingredient?
- Chlorhexidine gluconate, Isopropyl alcohol.
- Who is the labeler?
- Professional Disposables International, Inc., NDC labeler code 10819. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Prevantics Maxi Swabstick?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under NDA 021524
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 |
|---|---|---|---|---|
| Prevantics Swabchlorhexidine gluconate and isopropyl alcohol | Chlorhexidine gluconate 31.5 mg/mL; Isopropyl alcohol .7 mL/mL | SolutionTopical | Professional Disposables International, Inc. | 10819-1080 |
| Prevantics Swabstickchlorhexidine gluconate and isopropyl alcohol | Chlorhexidine gluconate 31.5 mg/mL; Isopropyl alcohol .7 mL/mL | SolutionTopical | Professional Disposables International, Inc. | 10819-4077 |