Over-the-counter drug · OTC MONOGRAPH DRUG
5406 hand sanitizer (Ethyl alcohol) NDC 76138-116
Alcohol 62 mL/100mL · Gel · Topical · Innovation Specialties
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76138-116-03 | 7613801160376138011603 | 30 mL in 1 CONTAINER (76138-116-03)Marketed from Jul 11, 2018 |
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)
- 5406 hand sanitizer
- Generic name (nonproprietary)
- ethyl alcohol
- Active ingredients
- Alcohol — 62 mL/100mL
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Innovation SpecialtiesNDC labeler code 76138
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 76138-116_1cee6f58-c80a-b22e-e063-6294a90ae32cSPL ID 1cee6f58-c80a-b22e-e063-6294a90ae32cSPL set ID 8d83b133-1240-4ec8-9fca-e4cbb84f6cafRxCUI 581660UNII 3K9958V90M
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
N476138011603followed by a unit qualifier and the quantityPackage 76138-0116-03. 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)
For handwashing to decrease bacteria on the skin.
Excerpt only. Read the full label for complete information.
About NDC 76138-116
- What is NDC 76138-116?
- 76138-116 is the product NDC for 5406 hand sanitizer (ethyl alcohol), Alcohol 62 mL/100mL gel, listed with the FDA by Innovation Specialties. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- 5406 hand sanitizer (Ethyl alcohol).
- What is the active ingredient?
- Alcohol.
- Who is the labeler?
- Innovation Specialties, NDC labeler code 76138. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for 5406 hand sanitizer?
- 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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