Over-the-counter drug · OTC MONOGRAPH DRUG
Ben E. Keith FIHS (Benzalkonium chloride) NDC 50980-207
Benzalkonium chloride 1.3 mg/mL · Solution · Topical · Ben E. Keith Foods
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50980-207-12 | 5098002071250980020712 | 1000 mL in 1 BAG (50980-207-12)Marketed from May 31, 2016 |
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)
- Ben E. Keith FIHS
- Generic name (nonproprietary)
- benzalkonium chloride
- Active ingredients
- Benzalkonium chloride — 1.3 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Ben E. Keith FoodsNDC labeler code 50980
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Marketing end
- Identifiers
- Product ID 50980-207_09c78743-cb8d-483c-a5f5-781cc220c0e2SPL ID 09c78743-cb8d-483c-a5f5-781cc220c0e2SPL set ID 4ca21370-1ecf-42c6-9c32-79cf994c336bRxCUI 1020365UNII F5UM2KM3W7UPC 0046045023604
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
N450980020712followed by a unit qualifier and the quantityPackage 50980-0207-12. 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 Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.
Excerpt only. Read the full label for complete information.
About NDC 50980-207
- What is NDC 50980-207?
- 50980-207 is the product NDC for Ben E. Keith FIHS (benzalkonium chloride), Benzalkonium chloride 1.3 mg/mL solution, listed with the FDA by Ben E. Keith Foods. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ben E. Keith FIHS (Benzalkonium Chloride).
- What is the active ingredient?
- Benzalkonium chloride.
- Who is the labeler?
- Ben E. Keith Foods, NDC labeler code 50980. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ben E. Keith FIHS?
- 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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