Over-the-counter drug · OTC MONOGRAPH DRUG
Sponge with 4% w/w chlorhexidine gluconate (CHG) (Chlorhexidine gluconate) NDC 84128-013
Chlorhexidine gluconate 40 mg/mL · Sponge · Topical · Xinxiang Xinda Technology Co.,Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84128-013-01 | 8412800130184128001301 | 40 BAG in 1 BOX (84128-013-01) / 1 APPLICATOR in 1 BAG / 20 mL in 1 APPLICATORMarketed from Feb 27, 2024 |
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)
- Sponge with 4% w/w chlorhexidine gluconate (CHG)
- Generic name (nonproprietary)
- chlorhexidine gluconate
- Active ingredients
- Chlorhexidine gluconate — 40 mg/mL
- Dosage form
- Sponge
- Route
- Topical
- Labeler
- Xinxiang Xinda Technology Co.,LtdNDC labeler code 84128
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 84128-013_53f4c42d-9a3c-2f33-e063-6294a90a98d4SPL ID 53f4c42d-9a3c-2f33-e063-6294a90a98d4SPL set ID 53f4dd22-e4ab-5d8a-e063-6294a90a8c39RxCUI 2677515UNII MOR84MUD8EUPC 6977191590105
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
N484128001301followed by a unit qualifier and the quantityPackage 84128-0013-01. 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 Preoperative cleaning of healthy skin,disinfectant for human hygiene.Significantly reduces the number of micro-organisms and clean on the health skin prior to surgery.
Excerpt only. Read the full label for complete information.
About NDC 84128-013
- What is NDC 84128-013?
- 84128-013 is the product NDC for Sponge with 4% w/w chlorhexidine gluconate (CHG), Chlorhexidine gluconate 40 mg/mL sponge, listed with the FDA by Xinxiang Xinda Technology Co.,Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sponge with 4% w/w chlorhexidine gluconate (CHG) (Chlorhexidine Gluconate).
- What is the active ingredient?
- Chlorhexidine gluconate.
- Who is the labeler?
- Xinxiang Xinda Technology Co.,Ltd, NDC labeler code 84128. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sponge with 4% w/w chlorhexidine gluconate (CHG)?
- 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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