Over-the-counter drug · NDA
Hibiclens (Chlorhexidine gluconate) NDC 76420-535
Chlorhexidine gluconate 4 g/100mL · Solution · Topical · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-535-08 | 7642005350876420053508 | 236 mL in 1 BOTTLE (76420-535-08)Marketed from Feb 3, 2023 |
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)
- Hibiclens
- Generic name (nonproprietary)
- chlorhexidine gluconate
- Active ingredients
- Chlorhexidine gluconate — 4 g/100mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Asclemed USA, Inc.NDC labeler code 76420
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017768
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 76420-535_23b4100e-49d1-0cb6-e063-6394a90a9d24SPL ID 23b4100e-49d1-0cb6-e063-6394a90a9d24SPL set ID c7363108-0b4e-4d8a-9ec8-ea048604ecb2RxCUI 211365, 834167UNII MOR84MUD8E
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
N476420053508followed by a unit qualifier and the quantityPackage 76420-0535-08. 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 antimicrobial skin cleanser helps to reduce bacteria that potentially can cause disease for skin wound and general skin cleansing surgical hand scrub healthcare peronnel handwash
Excerpt only. Read the full label for complete information.
About NDC 76420-535
- What is NDC 76420-535?
- 76420-535 is the product NDC for Hibiclens (chlorhexidine gluconate), Chlorhexidine gluconate 4 g/100mL solution, listed with the FDA by Asclemed USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hibiclens (Chlorhexidine Gluconate).
- What is the active ingredient?
- Chlorhexidine gluconate.
- Who is the labeler?
- Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hibiclens?
- 1 other product NDC are listed under this name. See all Hibiclens NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hibiclens products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hibiclenschlorhexidine gluconate | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Molnlycke Health Care | 0234-0575 | 00234-0575-0400234-0575-0800234-0575-16+2 more |
Other NDCs under NDA 017768
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Hibiclenschlorhexidine gluconate | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Molnlycke Health Care | 0234-0575 |