Over-the-counter drug · OTC MONOGRAPH DRUG
Epi-Clenz Pure Instant Hand Antiseptic (Ethyl alcohol) NDC 53329-203
Alcohol 70 mL/100mL · Gel · Topical · Medline Industries, LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53329-203-04 | 53329020304 | 118 mL in 1 BOTTLE (53329-203-04)Marketed from Apr 10, 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)
- Epi-Clenz Pure Instant Hand Antiseptic
- Generic name (nonproprietary)
- ethyl alcohol
- Active ingredients
- Alcohol — 70 mL/100mL
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Medline Industries, LPNDC labeler code 53329
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 53329-203_48343359-a967-5327-e063-6294a90a54e5SPL ID 48343359-a967-5327-e063-6294a90a54e5SPL set ID 9f2be060-0699-47ab-9398-efe91eef2267RxCUI 581662UNII 3K9958V90MUPC 0193489020079
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
N453329020304followed by a unit qualifier and the quantityPackage 53329-0203-04. 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 health care personnel hand rub to help reduce bacteria that potentially can cause disease recommended for repeated use
Excerpt only. Read the full label for complete information.
About NDC 53329-203
- What is NDC 53329-203?
- 53329-203 is the product NDC for Epi-Clenz Pure Instant Hand Antiseptic, Alcohol 70 mL/100mL gel, listed with the FDA by Medline Industries, LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Epi-Clenz Pure Instant Hand Antiseptic (Ethyl alcohol).
- What is the active ingredient?
- Alcohol.
- Who is the labeler?
- Medline Industries, LP, NDC labeler code 53329. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Epi-Clenz Pure Instant Hand Antiseptic?
- 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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