Over-the-counter drug · OTC MONOGRAPH DRUG
Alcohol Swabstick (Isopropyl alcohol) NDC 34645-0016
Isopropyl alcohol 70 mL/g · Swab · Topical · Jianerkang Medical Co., Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 34645-0016-1 | 3464500160134645001601 | 1 APPLICATOR in 1 POUCH (34645-0016-1) / 2 g in 1 APPLICATORMarketed from Aug 1, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Alcohol Swabstick
- Generic name (nonproprietary)
- isopropyl alcohol
- Active ingredients
- Isopropyl alcohol — 70 mL/g
- Dosage form
- Swab
- Route
- Topical
- Labeler
- Jianerkang Medical Co., LtdNDC labeler code 34645
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 34645-0016_085ec0ff-b5c2-2628-e063-6294a90ade13SPL ID 085ec0ff-b5c2-2628-e063-6294a90ade13SPL set ID b576911b-bbf2-4ce7-a94a-29bbf719f205RxCUI 797544UNII ND2M416302
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
N434645001601followed by a unit qualifier and the quantityPackage 34645-0016-01. 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)
USE For skin cleansing prior to injection
Excerpt only. Read the full label for complete information.
About NDC 34645-0016
- What is NDC 34645-0016?
- 34645-0016 is the product NDC for Alcohol Swabstick (isopropyl alcohol), Isopropyl alcohol 70 mL/g swab, listed with the FDA by Jianerkang Medical Co., Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Alcohol Swabstick (Isopropyl alcohol).
- What is the active ingredient?
- Isopropyl alcohol.
- Who is the labeler?
- Jianerkang Medical Co., Ltd, NDC labeler code 34645. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Alcohol Swabstick?
- 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.
Showing 20 of 40.