Prescription drug · NDA
Antiseptic Skin Cleanser (Chlorhexidine gluconate) NDC 0116-0407
Chlorhexidine gluconate 4 g/100mL · Solution · Topical · Xttrium Laboratories, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0116-0407Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00116-0407Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0116-0407-01 | 0011604070100116040701 | 237 mL in 1 BOTTLE, PLASTIC (0116-0407-01)Marketed from Jan 1, 2012 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Active ingredients
- Chlorhexidine gluconate — 4 g/100mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Xttrium Laboratories, Inc.NDC labeler code 0116
- Product type
- Prescription 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 0116-0407_50762eee-e13a-4d7f-e063-6294a90a777cSPL ID 50762eee-e13a-4d7f-e063-6294a90a777cSPL set ID 4a9eda34-d85c-4b66-e054-00144ff88e88RxCUI 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
N400116040701followed by a unit qualifier and the quantityPackage 00116-0407-01. 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)
Uses 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 0116-0407
- What is NDC 0116-0407?
- 0116-0407 is the product NDC for Antiseptic Skin Cleanser (chlorhexidine gluconate), Chlorhexidine gluconate 4 g/100mL solution, listed with the FDA by Xttrium Laboratories, Inc.. 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).
- What is the active ingredient?
- Chlorhexidine gluconate.
- Who is the labeler?
- Xttrium Laboratories, Inc., NDC labeler code 0116. 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 | Topco Associates LLC | 36800-401 | 36800-0401-50 |
| 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 |
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 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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