Over-the-counter drug · OTC MONOGRAPH DRUG
Antibacterial Hand Cleanser (Benzalkonium chloride) NDC 50865-215
Benzalkonium chloride .013 mg/mL · Soap · Topical · Kutol Products Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50865-215-09 | 5086502150950865021509 | 3785 mL in 1 BOTTLE, PLASTIC (50865-215-09)Marketed from Aug 17, 2017 | |
| 50865-215-12 | 5086502151250865021512 | 1200 mL in 1 BAG (50865-215-12)Marketed from Aug 17, 2017 | |
| 50865-215-19 | 5086502151950865021519 | 237 mL in 1 BOTTLE, PUMP (50865-215-19)Marketed from Aug 17, 2017 | |
| 50865-215-65 | 5086502156550865021565 | 800 mL in 1 BAG (50865-215-65)Marketed from Aug 17, 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)
- Antibacterial Hand Cleanser
- Generic name (nonproprietary)
- benzalkonium chloride
- Active ingredients
- Benzalkonium chloride — .013 mg/mL
- Dosage form
- Soap
- Route
- Topical
- Labeler
- Kutol Products CompanyNDC labeler code 50865
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 50865-215_03fbe342-a3b7-9a63-e063-6294a90a15f2SPL ID 03fbe342-a3b7-9a63-e063-6294a90a15f2SPL set ID 56f50eda-5399-1bfe-e054-00144ff8d46cUNII F5UM2KM3W7UPC 0686702050095
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
N450865021509followed by a unit qualifier and the quantityPackage 50865-0215-09. 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 Handwash to decrease bacteria on the skin.
Excerpt only. Read the full label for complete information.
About NDC 50865-215
- What is NDC 50865-215?
- 50865-215 is the product NDC for Antibacterial Hand Cleanser (benzalkonium chloride), Benzalkonium chloride .013 mg/mL soap, listed with the FDA by Kutol Products Company. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Antibacterial Hand Cleanser (Benzalkonium chloride).
- What is the active ingredient?
- Benzalkonium chloride.
- Who is the labeler?
- Kutol Products Company, NDC labeler code 50865. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Antibacterial Hand Cleanser?
- 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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