Over-the-counter drug · NDA
foaming hand wash (Chlorhexidine gluconate) NDC 53329-994
Chlorhexidine gluconate 20 mg/mL · Liquid · Topical · Medline Industries, LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53329-994-84 | 5332909948453329099484 | 1000 mL in 1 BOTTLE (53329-994-84)Marketed from Jan 1, 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)
- foaming hand wash
- Generic name (nonproprietary)
- chlorhexidine gluconate
- Active ingredients
- Chlorhexidine gluconate — 20 mg/mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- Medline Industries, LPNDC labeler code 53329
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019422
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 53329-994_3e4fe7f8-b082-5ac2-e063-6394a90afc08SPL ID 3e4fe7f8-b082-5ac2-e063-6394a90afc08SPL set ID 9b926809-65e9-4e5b-e053-2995a90add10RxCUI 1245230UNII MOR84MUD8EUPC 0193489102515
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
N453329099484followed by a unit qualifier and the quantityPackage 53329-0994-84. 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 • surgical hand scrub : significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care • healthcare personnel handwash : helps reduce bacteria that potentially can cause disease
Excerpt only. Read the full label for complete information.
About NDC 53329-994
- What is NDC 53329-994?
- 53329-994 is the product NDC for foaming hand wash (chlorhexidine gluconate), Chlorhexidine gluconate 20 mg/mL liquid, 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?
- foaming hand wash (Chlorhexidine gluconate).
- What is the active ingredient?
- Chlorhexidine gluconate.
- 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 foaming hand wash?
- 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 NDA 019422
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 |
|---|---|---|---|---|
| Antimicrobial Foam Handwashchlorhexidine gluconate 2% solution | Chlorhexidine gluconate 20 mg/mL | LiquidTopical | GOJO Industries, Inc. | 21749-416 |
| Antimicrobial Skin Cleanserchlorhexidine gluconate 2% solution | Chlorhexidine gluconate 20 mg/mL | LiquidTopical | Gojo Industries, Inc. | 21749-106 |
| Antiseptic Foam Handwashchlorhexidine gluconate 2% solution | Chlorhexidine gluconate 20 mg/mL | LiquidTopical | GOJO Industries, Inc. | 21749-461 |
| Bactoshield CHGchlorhexidine gluconate 2% | Chlorhexidine gluconate 2 mg/100mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-0038 |
| Bactoshield CHG Chlorhexidine Gluconatechlorhexidine gluconate | Chlorhexidine gluconate 20 mg/mL | SolutionTopical | SC Johnson Professional USA, Inc. | 11084-038 |
| Dyna-Hex 2chlorhexidine gluconate | Chlorhexidine gluconate 2 g/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-1021 |
| Dyna-Hex 2chlorhexidine gluconate 2% | Chlorhexidine gluconate 20 mg/mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-1022 |
| Provon Antimicrobial Foam Handwashchlorhexidine gluconate 2% | Chlorhexidine gluconate 20 mg/mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-8500 |
| Provon Antimicrobial Foam Handwashchlorhexidine gluconate 2% | Chlorhexidine gluconate 20 mg/mL | SolutionTopical | Gojo Industries, Inc. | 21749-850 |
| Purell Antimicrobial Foamchlorhexidine gluconate 2% solution | Chlorhexidine gluconate 20 mg/mL | LiquidTopical | GOJO Industries, Inc. | 21749-225 |