Over-the-counter drug · OTC MONOGRAPH DRUG
Natural Concepts Hand Sanitizer (Ethyl alcohol) NDC 63148-516
Alcohol 650 mg/mL · Gel · Topical · Apollo Health and Beauty Care
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63148-516-03 | 6314805160363148051603 | 59 mL in 1 BOTTLE, PLASTIC (63148-516-03)Marketed from May 11, 2020 | |
| 63148-516-09 | 6314805160963148051609 | 236 mL in 1 BOTTLE, PLASTIC (63148-516-09)Marketed from May 11, 2020 | |
| 63148-516-33 | 6314805163363148051633 | 946 mL in 1 BOTTLE, PLASTIC (63148-516-33)Marketed from May 11, 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)
- Natural Concepts Hand Sanitizer
- Generic name (nonproprietary)
- ethyl alcohol
- Active ingredients
- Alcohol — 650 mg/mL
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Apollo Health and Beauty CareNDC labeler code 63148
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 63148-516_513b7d15-7d64-3775-e063-6394a90adf9cSPL ID 513b7d15-7d64-3775-e063-6394a90adf9cSPL set ID b25bbf28-f08d-4de2-9be7-bfb6b134b49aRxCUI 902574UNII 3K9958V90MUPC 0670456000536, 0670456000543
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
N463148051603followed by a unit qualifier and the quantityPackage 63148-0516-03. 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)
Uses for personal hand hygiene to help prevent the spread of bacteria, and can be used in place of hand washing if soap and water are not available.
Excerpt only. Read the full label for complete information.
About NDC 63148-516
- What is NDC 63148-516?
- 63148-516 is the product NDC for Natural Concepts Hand Sanitizer (ethyl alcohol), Alcohol 650 mg/mL gel, listed with the FDA by Apollo Health and Beauty Care. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Natural Concepts Hand Sanitizer (Ethyl Alcohol).
- What is the active ingredient?
- Alcohol.
- Who is the labeler?
- Apollo Health and Beauty Care, NDC labeler code 63148. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Natural Concepts 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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