Over-the-counter drug · OTC MONOGRAPH DRUG
Zylast Antiseptic (Ethyl alcohol) NDC 57362-465
Alcohol 44.9 mL/59.1mL · Gel · Topical · Innovative BioDefense
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57362-465-01 | 5736204650157362046501 | 59.1 mL in 1 BOTTLE, PLASTIC (57362-465-01)Marketed from Jan 15, 2019 | |
| 57362-465-14 | 5736204651457362046514 | 1000 mL in 1 CARTRIDGE (57362-465-14)Marketed from Apr 24, 2015 |
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
- Generic name (nonproprietary)
- ethyl alcohol
- Active ingredients
- Alcohol — 44.9 mL/59.1mL
- Dosage form
- Gel
- 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 57362-465_4034b4f1-0357-ad88-e063-6294a90ac287SPL ID 4034b4f1-0357-ad88-e063-6294a90ac287SPL set ID 178190dc-7c68-6485-e054-00144ff8d46cRxCUI 1535597UNII 3K9958V90MUPC 0094922464132
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
N457362046501followed by a unit qualifier and the quantityPackage 57362-0465-01. 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)
To decrease bacteria on skin. Recommended for repeated use.
Excerpt only. Read the full label for complete information.
About NDC 57362-465
- What is NDC 57362-465?
- 57362-465 is the product NDC for Zylast Antiseptic (ethyl alcohol), Alcohol 44.9 mL/59.1mL gel, listed with the FDA by Innovative BioDefense. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zylast Antiseptic (Ethyl Alcohol).
- What is the active ingredient?
- Alcohol.
- 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?
- 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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