Over-the-counter drug · NDA
CliniClean (Chlorhexidine gluconate 4%) NDC 69464-901
Chlorhexidine gluconate 4 g/100mL · Solution · Topical · HR Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69464-901-16 | 6946409011669464090116 | 473 mL in 1 BOTTLE (69464-901-16)Marketed from Mar 23, 2023 | |
| 69464-901-32 | 6946409013269464090132 | 946 mL in 1 BOTTLE (69464-901-32)Marketed from Mar 23, 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)
- CliniClean
- Generic name (nonproprietary)
- chlorhexidine gluconate 4%
- Active ingredients
- Chlorhexidine gluconate — 4 g/100mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- HR Pharmaceuticals, Inc.NDC labeler code 69464
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019125
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 69464-901_461403d2-2038-2ff8-e063-6394a90a7d59SPL ID 461403d2-2038-2ff8-e063-6394a90a7d59SPL set ID f7959667-6275-802a-e053-6394a90aa7f1RxCUI 211365UNII MOR84MUD8EUPC 0694640161162, 0694640161087
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
N469464090116followed by a unit qualifier and the quantityPackage 69464-0901-16. 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 cleansing
Excerpt only. Read the full label for complete information.
About NDC 69464-901
- What is NDC 69464-901?
- 69464-901 is the product NDC for CliniClean (chlorhexidine gluconate 4%), Chlorhexidine gluconate 4 g/100mL solution, listed with the FDA by HR Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CliniClean (Chlorhexidine gluconate 4%).
- What is the active ingredient?
- Chlorhexidine gluconate.
- Who is the labeler?
- HR Pharmaceuticals, Inc., NDC labeler code 69464. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for CliniClean?
- 1 other product NDC are listed under this name. See all CliniClean NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other CliniClean products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| CliniCleanchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-0901 | 00116-0901-32 |
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 |
| 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 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Topco Associates LLC | 36800-401 |
| 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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