Over-the-counter drug · OTC MONOGRAPH DRUG
Zylast Antiseptic K (Benzalkonium chloride) NDC 57362-468
Benzalkonium chloride .13 g/100mL · Lotion · Topical · Innovative Biodefense
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57362-468-00 | 5736204680057362046800 | 59.1 mL in 1 BOTTLE, DISPENSING (57362-468-00)Marketed from Jan 1, 2020 | |
| 57362-468-03 | 5736204680357362046803 | 236.6 mL in 1 BOTTLE, PUMP (57362-468-03)Marketed from Jan 1, 2020 | |
| 57362-468-04 | 5736204680457362046804 | 14.8 mL in 1 TUBE (57362-468-04)Marketed from Jan 1, 2020 | |
| 57362-468-05 | 5736204680557362046805 | 1000 mL in 1 CARTRIDGE (57362-468-05)Marketed from Jan 1, 2020 |
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)
- Zylast Antiseptic K
- Generic name (nonproprietary)
- benzalkonium chloride
- Active ingredients
- Benzalkonium chloride — .13 g/100mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Innovative BiodefenseNDC labeler code 57362
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 57362-468_050d6202-97f5-7c43-e063-6294a90a1d74SPL ID 050d6202-97f5-7c43-e063-6294a90a1d74SPL set ID 84766b3b-915c-b604-e053-2a91aa0a672cRxCUI 1046442UNII F5UM2KM3W7UPC 0040232338182, 0040232338168, 0040232338151
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
N457362046800followed by a unit qualifier and the quantityPackage 57362-0468-00. 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 To decrease bacteria on skin. Recommended for repeated use.
Excerpt only. Read the full label for complete information.
About NDC 57362-468
- What is NDC 57362-468?
- 57362-468 is the product NDC for Zylast Antiseptic K (benzalkonium chloride), Benzalkonium chloride .13 g/100mL lotion, listed with the FDA by Innovative Biodefense. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zylast Antiseptic K (Benzalkonium Chloride).
- What is the active ingredient?
- Benzalkonium chloride.
- Who is the labeler?
- Innovative Biodefense, NDC labeler code 57362. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zylast Antiseptic K?
- 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 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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