Prescription drug · ANDA
Chlorhexidine Gluconate Oral Rinse NDC 16571-128
Chlorhexidine gluconate 1.2 mg/mL · Solution · Dental · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-128-48 | 16571012848 | 473 mL in 1 BOTTLE (16571-128-48)Marketed from Jul 27, 2023 | |
| 16571-128-52 | 16571012852 | 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (16571-128-52) / 15 mL in 1 CUP, UNIT-DOSE (16571-128-15)Marketed from Apr 1, 2024 |
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 Oral Rinse
- Generic name (nonproprietary)
- chlorhexidine gluconate oral rinse
- Active ingredients
- Chlorhexidine gluconate — 1.2 mg/mL
- Dosage form
- Solution
- Route
- Dental
- Labeler
- Rising Pharma Holdings, Inc.
- 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 16571-128_ef0aace4-0140-4eb9-8756-83414d6dd2e3SPL ID ef0aace4-0140-4eb9-8756-83414d6dd2e3SPL set ID b6b45b87-aa53-4d3a-be59-f3d3b0774a7bRxCUI 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
N416571012848followed by a unit qualifier and the quantityPackage 16571-0128-48. 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.
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, 0.12% Oral Rinse Solutionchlorhexidine gluconate, 0.12% oral rinse | Chlorhexidine gluconate 1.2 mg/mL | SolutionDental | Kesin Pharma Corporation | 81033-512 |
| 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 Oral Rinse | Chlorhexidine gluconate 1.2 mg/mL | SolutionDental | Atlantic Biologicals Corp. | 17856-2128 |
| Chlorhexidine Gluconate, 0.12% Oral Rinse Solution | Chlorhexidine gluconate 1.2 mg/mL | SolutionDental | Bajaj Medical, LLC | 61037-469 |
| 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 |
| CleanCare Chlorhexidine Gluconate 0.12% Oral Rinsechlorhexidine gluconate | Chlorhexidine gluconate 1.2 mg/mL | SolutionDental | Safco Dental Supply LLC | 67239-0225 |
| CleanCare Chlorhexidine Gluconate 0.12% Oral Rinsechlorhexidine gluconate | Chlorhexidine gluconate 1.2 mg/mL | SolutionDental | Safco Dental Supply LLC | 67239-0225 |
| Chlorhexidine Gluconate, 0.12% Oral Rinse | Chlorhexidine gluconate 1.2 mg/mL | SolutionDental | American Health Packaging | 60687-714 |