Over-the-counter drug · OTC MONOGRAPH DRUG
BioPure Antibacterial Hand Wipes Benzalkonium Chloride 0.12% - 250 Wipes (Benzalkonium chloride) NDC 78691-009
Benzalkonium chloride 1.2 mg/mL · Cloth · Topical · QUEST USA CORP.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78691-009-00 | 7869100090078691000900 | 250 PATCH in 1 CONTAINER (78691-009-00) / 2.8 mL in 1 PATCHMarketed from Sep 20, 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)
- BioPure Antibacterial Hand Wipes Benzalkonium Chloride 0.12% - 250 Wipes
- Generic name (nonproprietary)
- benzalkonium chloride
- Active ingredients
- Benzalkonium chloride — 1.2 mg/mL
- Dosage form
- Cloth
- Route
- Topical
- Labeler
- QUEST USA CORP.NDC labeler code 78691
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 78691-009_47485d18-f49b-df6b-e063-6294a90a46a4SPL ID 47485d18-f49b-df6b-e063-6294a90a46a4SPL set ID ae2fdb32-05c6-6d16-e053-2995a90a552dRxCUI 1038741UNII F5UM2KM3W7UPC 0842700165159
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
N478691000900followed by a unit qualifier and the quantityPackage 78691-0009-00. 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 • Hand sanitizer to help reduce bacteria. • For use when soap and water are not available.
Excerpt only. Read the full label for complete information.
About NDC 78691-009
- What is NDC 78691-009?
- 78691-009 is the product NDC for BioPure Antibacterial Hand Wipes Benzalkonium Chloride 0.12% - 250 Wipes, Benzalkonium chloride 1.2 mg/mL cloth, listed with the FDA by QUEST USA CORP.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- BioPure Antibacterial Hand Wipes Benzalkonium Chloride 0.12% - 250 Wipes (Benzalkonium chloride).
- What is the active ingredient?
- Benzalkonium chloride.
- Who is the labeler?
- QUEST USA CORP., NDC labeler code 78691. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for BioPure Antibacterial Hand Wipes Benzalkonium Chloride 0.12% - 250 Wipes?
- 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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