Over-the-counter drug · OTC MONOGRAPH DRUG
Total Solutions Hygien Hand (Benzalkonium) NDC 62819-268
Benzalkonium chloride .12 g/100mL · Soap · Topical · Athea Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62819-268-01 | 6281902680162819026801 | 3785 mL in 1 BOTTLE, PLASTIC (62819-268-01)Marketed from Jan 18, 2013 | |
| 62819-268-02 | 6281902680262819026802 | 473 mL in 1 BOTTLE, PLASTIC (62819-268-02)Marketed from Jan 18, 2013 |
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)
- Total Solutions Hygien Hand
- Generic name (nonproprietary)
- benzalkonium
- Active ingredients
- Benzalkonium chloride — .12 g/100mL
- Dosage form
- Soap
- Route
- Topical
- Labeler
- Athea Laboratories, Inc.NDC labeler code 62819
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 62819-268_2a8551bf-9018-2a4d-e063-6294a90a15e7SPL ID 2a8551bf-9018-2a4d-e063-6294a90a15e7SPL set ID fcd63fe4-a357-4432-a738-ae1bccbb8baeRxCUI 1053188UNII F5UM2KM3W7
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
N462819026801followed by a unit qualifier and the quantityPackage 62819-0268-01. 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)
Uses ■ For handwashing to help reduce bacteria on skin. ■ After changing diapers. ■ After assisting ill persons. ■ Before contact with a person under medical care or treatment. ■ Recommended for repeat use.
Excerpt only. Read the full label for complete information.
About NDC 62819-268
- What is NDC 62819-268?
- 62819-268 is the product NDC for Total Solutions Hygien Hand (benzalkonium), Benzalkonium chloride .12 g/100mL soap, listed with the FDA by Athea Laboratories, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Total Solutions Hygien Hand (Benzalkonium).
- What is the active ingredient?
- Benzalkonium chloride.
- Who is the labeler?
- Athea Laboratories, Inc., NDC labeler code 62819. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Total Solutions Hygien Hand?
- 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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