Prescription drug · ANDA
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution NDC 61037-469
Chlorhexidine gluconate 1.2 mg/mL · Solution · Dental · Bajaj Medical, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61037-469-02 | 6103704690261037046902 | 118 mL in 1 BOTTLE (61037-469-02)Marketed from Nov 17, 2021 | |
| 61037-469-03 | 6103704690361037046903 | 473 mL in 1 BOTTLE (61037-469-03)Marketed from Nov 17, 2021 | |
| 61037-469-05 | 6103704690561037046905 | 1893 mL in 1 JUG (61037-469-05)Marketed from Nov 17, 2021 | |
| 61037-469-07 | 6103704690761037046907 | 15 mL in 1 CUP, UNIT-DOSE (61037-469-07)Marketed from Nov 17, 2021 |
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 solution
- Active ingredients
- Chlorhexidine gluconate — 1.2 mg/mL
- Dosage form
- Solution
- Route
- Dental
- Labeler
- Bajaj Medical, LLCNDC labeler code 61037
- 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 61037-469_0dfd551e-3e6f-769f-e063-6294a90ad610SPL ID 0dfd551e-3e6f-769f-e063-6294a90ad610SPL set ID d44f4e79-e684-a1ef-e053-2995a90a4620RxCUI 834127UNII MOR84MUD8EUPC 0361037469025, 0361037469032
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
N461037046902followed by a unit qualifier and the quantityPackage 61037-0469-02. 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 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 61037-469
- What is NDC 61037-469?
- 61037-469 is the product NDC for Chlorhexidine Gluconate, 0.12% Oral Rinse Solution, Chlorhexidine gluconate 1.2 mg/mL solution, listed with the FDA by Bajaj Medical, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Chlorhexidine Gluconate, 0.12% Oral Rinse Solution.
- What is the active ingredient?
- Chlorhexidine gluconate.
- Who is the labeler?
- Bajaj Medical, LLC, NDC labeler code 61037. 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 Solutionchlorhexidine gluconate, 0.12% oral rinse | Chlorhexidine gluconate 1.2 mg/mL | SolutionDental | Kesin Pharma Corporation | 81033-512 | 81033-0512-50 |
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 Solutionchlorhexidine gluconate, 0.12% oral rinse | Chlorhexidine gluconate 1.2 mg/mL | SolutionDental | A2A Integrated Pharmaceuticals, LLC | 73141-512 |
| Chlorhexidine Gluconate, 0.12% Oral Rinse Solutionchlorhexidine gluconate, 0.12% oral rinse | Chlorhexidine gluconate 1.2 mg/mL | SolutionDental | Kesin Pharma Corporation | 81033-512 |
| CleanCare Chlorhexidine Gluconate 0.12% Oral Rinsechlorhexidine gluconate | Chlorhexidine gluconate 1.2 mg/mL | SolutionDental | Safco Dental Supply LLC | 67239-0225 |