Prescription drug · ANDA
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution NDC 81033-512
chlorhexidine gluconate, 0.12% oral rinse · Chlorhexidine gluconate 1.2 mg/mL · Solution · Dental · Kesin Pharma Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81033-512-50 | 8103305125081033051250 | 100 CUP, UNIT-DOSE in 1 CARTON (81033-512-50) / 15 mL in 1 CUP, UNIT-DOSE (81033-512-15)Marketed from Aug 15, 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)
- Chlorhexidine Gluconate, 0.12% Oral Rinse Solution
- Generic name (nonproprietary)
- chlorhexidine gluconate, 0.12% oral rinse
- Active ingredients
- Chlorhexidine gluconate — 1.2 mg/mL
- Dosage form
- Solution
- Route
- Dental
- Labeler
- Kesin Pharma CorporationNDC labeler code 81033
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075561
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 81033-512_2d91fb6c-a2a4-5fcf-e063-6294a90aa15cSPL ID 2d91fb6c-a2a4-5fcf-e063-6294a90aa15cSPL set ID 326c15fc-90d8-48de-abd0-61e0c4165529RxCUI 834127UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N481033051250followed by a unit qualifier and the quantityPackage 81033-0512-50. 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)
INDICATION INDICATION Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.
Excerpt only. Read the full label for complete information.
About NDC 81033-512
- What is NDC 81033-512?
- 81033-512 is the product NDC for Chlorhexidine Gluconate, 0.12% Oral Rinse Solution, Chlorhexidine gluconate 1.2 mg/mL solution, listed with the FDA by Kesin Pharma Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Chlorhexidine Gluconate, 0.12% Oral Rinse Solution (Chlorhexidine Gluconate, 0.12% Oral Rinse).
- What is the active ingredient?
- Chlorhexidine gluconate.
- Who is the labeler?
- Kesin Pharma Corporation, NDC labeler code 81033. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Chlorhexidine Gluconate, 0.12% Oral Rinse Solution?
- 2 other product NDCs are listed under this name. See all Chlorhexidine Gluconate, 0.12% Oral Rinse Solution NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Chlorhexidine Gluconate, 0.12% Oral Rinse Solution products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Chlorhexidine Gluconate, 0.12% Oral Rinse Solutionchlorhexidine gluconate, 0.12% oral rinse | Chlorhexidine gluconate 1.2 mg/mL | SolutionDental | A2A Integrated Pharmaceuticals, LLC | 73141-512 | 73141-0512-50 |
| Chlorhexidine Gluconate, 0.12% Oral Rinse Solution | Chlorhexidine gluconate 1.2 mg/mL | SolutionDental | Bajaj Medical, LLC | 61037-469 | 61037-0469-0261037-0469-0361037-0469-05+1 more |
Other NDCs under ANDA 075561
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 |
|---|---|---|---|---|
| Chlorhexidine Gluconate Oral Rinse | Chlorhexidine gluconate 1.2 mg/mL | SolutionDental | Rising Pharma Holdings, Inc. | 16571-128 |
| Chlorhexidine Gluconate Oral Rinse | Chlorhexidine gluconate 1.2 mg/mL | SolutionDental | Atlantic Biologicals Corp. | 17856-2128 |
| Chlorhexidine Gluconate Oral Rinse | Chlorhexidine gluconate 1.2 mg/mL | SolutionDental | NuCare Pharmaceuticals,Inc. | 68071-3630 |
| Chlorhexidine Gluconate Oral Rinse | Chlorhexidine gluconate 1.2 mg/mL | SolutionDental | Brisk Pharmaceuticals | 73614-203 |
| Chlorhexidine Gluconate, 0.12% Oral Rinse | Chlorhexidine gluconate 1.2 mg/mL | SolutionDental | American Health Packaging | 60687-714 |
| Chlorhexidine Gluconate, 0.12% Oral Rinse Solution | Chlorhexidine gluconate 1.2 mg/mL | SolutionDental | Bajaj Medical, LLC | 61037-469 |
| Chlorhexidine Gluconate, 0.12% Oral Rinse Solutionchlorhexidine gluconate, 0.12% oral rinse | Chlorhexidine gluconate 1.2 mg/mL | SolutionDental | A2A Integrated Pharmaceuticals, LLC | 73141-512 |
| CleanCare Chlorhexidine Gluconate 0.12% Oral Rinsechlorhexidine gluconate | Chlorhexidine gluconate 1.2 mg/mL | SolutionDental | Safco Dental Supply LLC | 67239-0225 |