Over-the-counter drug · NDA
Antiseptic Skin Cleanser (Chlorhexidine gluconate 4%) NDC 36800-401
Chlorhexidine gluconate 4 mg/100mL · Liquid · Topical · Topco Associates LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)36800-401Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0401Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-401-50 | 3680004015036800040150 | 237 mL in 1 BOTTLE, PLASTIC (36800-401-50)Marketed from Nov 1, 2013 |
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)
- Antiseptic Skin Cleanser
- Generic name (nonproprietary)
- chlorhexidine gluconate 4%
- Active ingredients
- Chlorhexidine gluconate — 4 mg/100mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- Topco Associates LLCNDC labeler code 36800
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019125
- Marketing start
- Marketing end
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 36800-401_45c4ec2b-ec70-57db-e063-6294a90a1b38SPL ID 45c4ec2b-ec70-57db-e063-6294a90a1b38SPL set ID a0b7180a-0257-4a64-9d1a-6b6d824fac1cRxCUI 211365UNII 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
N436800040150followed by a unit qualifier and the quantityPackage 36800-0401-50. 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 skin wound and general skin cleansing
Excerpt only. Read the full label for complete information.
About NDC 36800-401
- What is NDC 36800-401?
- 36800-401 is the product NDC for Antiseptic Skin Cleanser (chlorhexidine gluconate 4%), Chlorhexidine gluconate 4 mg/100mL liquid, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Antiseptic Skin Cleanser (Chlorhexidine Gluconate 4%).
- What is the active ingredient?
- Chlorhexidine gluconate.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Antiseptic Skin Cleanser?
- 17 other product NDCs are listed under this name. See all Antiseptic Skin Cleanser NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Antiseptic Skin Cleanser products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Rite Aid | 11822-0891 | 11822-0891-02 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | LiquidTopical | Rite Aid | 11822-0116 | 11822-0116-05 |
| Antiseptic Skin Cleanserchlorhexidine gluconate | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | McKesson Medical-Surgical | 68599-5401 | 68599-5401-0068599-5401-0768599-5401-08 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Chain Drug Marketing Association Inc. | 63868-940 | 63868-0940-08 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Meijer Distribution, Inc. | 41250-162 | 41250-0162-16 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-0401 | 00116-0401-50 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-0137 | 00116-0137-3400116-0137-43 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | AmerisourceBergen Drug Corporation | 46122-137 | 46122-0137-3446122-0137-43 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-3678 | 00116-3678-0700116-3678-08 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Rite Aid Corporation | 11822-3678 | 11822-3678-0711822-3678-08 |
Other NDCs under NDA 019125
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 |
|---|---|---|---|---|
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | AmerisourceBergen Drug Corporation | 46122-137 |
| Foster and Thrivechlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | McKesson Corporation | 70677-1221 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Chain Drug Marketing Association Inc. | 63868-940 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-3678 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-0137 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-0161 |
| Betaseptantiseptic surgical scrub | Chlorhexidine gluconate .04 mg/mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-0200 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-0401 |
| CliniCleanchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | HR Pharmaceuticals, Inc. | 69464-901 |
| Antiseptic Skin Cleanserchlorhexidine gluconate | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-0407 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Rite Aid | 11822-0891 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-0767 |
| Antiseptic Solutionchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Coloplast Corp | 11701-172 |
| CliniCleanchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-0901 |
| Betaseptantiseptic surgical scrub | Chlorhexidine gluconate .04 mg/mL | SolutionTopical | Atlantis Consumer Healthcare, Inc. | 67618-200 |
| Antiseptic Skin Cleanserchlorhexidine gluconate | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | McKesson Medical-Surgical | 68599-5401 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | LiquidTopical | CVS Pharmacy, Inc. | 59779-767 |
| Dyna-Hex 4chlorhexidine gluconate | Chlorhexidine gluconate 4 g/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-1060 |
| Antiseptic Skin Cleanserchlorhexidine gluconate | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-1061 |
| Antiseptic Skin Cleanserchlorhexidine gluconate | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-1061 |
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