Prescription drug · ANDA
Chlorhexidine Gluconate NDC 66689-106
Chlorhexidine gluconate 1.2 mg/mL · Rinse · Buccal · VistaPharm, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66689-106-50 | 6668901065066689010650 | 50 CUP, UNIT-DOSE in 1 CASE (66689-106-50) / 15 mL in 1 CUP, UNIT-DOSE (66689-106-01)Marketed from Jan 24, 2022 | |
| 66689-106-99 | 6668901069966689010699 | 100 CUP, UNIT-DOSE in 1 CASE (66689-106-99) / 15 mL in 1 CUP, UNIT-DOSE (66689-106-01)Marketed from Jan 24, 2022 |
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
- Generic name (nonproprietary)
- chlorhexidine gluconate
- Active ingredients
- Chlorhexidine gluconate — 1.2 mg/mL
- Dosage form
- Rinse
- Route
- Buccal
- Labeler
- VistaPharm, LLCNDC labeler code 66689
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203212
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 66689-106_5674e1f6-64de-4e08-990e-d3e7cbcd3070SPL ID 5674e1f6-64de-4e08-990e-d3e7cbcd3070SPL set ID 7fb18b56-a76d-4f15-9438-c941def76fdbRxCUI 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 HCPCS code in Med-Code's directory. Buccal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N466689010650followed by a unit qualifier and the quantityPackage 66689-0106-50. 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)
INDICATIONS AND USAGE: Chlorhexidine gluconate oral rinse USP, 0.12% 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 USP, 0.12% 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 66689-106
- What is NDC 66689-106?
- 66689-106 is the product NDC for Chlorhexidine Gluconate, Chlorhexidine gluconate 1.2 mg/mL rinse, listed with the FDA by VistaPharm, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Chlorhexidine Gluconate.
- What is the active ingredient?
- Chlorhexidine gluconate.
- Who is the labeler?
- VistaPharm, LLC, NDC labeler code 66689. 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?
- 23 other product NDCs are listed under this name. See all Chlorhexidine Gluconate 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 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 | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Xttrium Laboratories, Inc. | 0116-1999 | 00116-1999-16 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | PAI Holdings, LLC dba PAI Pharma | 0121-1786 | 00121-1786-16 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | REMEDYREPACK INC. | 70518-4494 | 70518-4494-00 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 40 mg/mL | SolutionTopical | Rising Pharma Holdings, Inc. | 16571-111 | 16571-0111-1216571-0111-2416571-0111-48+1 more |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseDental | Major Pharmaceuticals | 0904-7035 | 00904-7035-8000904-7035-87 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Lyne Laboratories, Inc. | 0374-5080 | 00374-5080-0100374-5080-02 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate .12 mg/mL | LiquidOral | Xttrium Laboratories, Inc. | 0116-0101 | 00116-0101-0100116-0101-04 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Preferred Pharmaceuticals, Inc. | 68788-9546 | 68788-9546-04 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Xttrium Laboratories, Inc. | 0116-6000 | 00116-6000-0400116-6000-16 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Benco Dental | 66975-600 | 66975-0600-0466975-0600-16 |
Other NDCs under ANDA 203212
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 |
|---|---|---|---|---|
| Periogard Alcohol Freechlorhexidine gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseBuccal | Colgate Oral Pharmaceuticals, Inc. | 0126-0272 |
| Periogard Alcohol Freechlorhexidine gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseBuccal | Colgate Oral Pharmaceuticals, Inc. | 0126-0282 |
| Periogard Alcohol Freechlorhexidine gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseBuccal | ATLANTIC BIOLOGICALS CORP. | 17856-0272 |