Prescription drug · ANDA
Chlorhexidine Gluconate 0.12% Oral Rinse NDC 62135-650
Chlorhexidine gluconate 1.2 mg/mL · Solution · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-650-24 | 62135065024 | 2 TRAY in 1 BOX (62135-650-24) / 10 CUP in 1 TRAY / 15 mL in 1 CUP (62135-650-51)Marketed from May 23, 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 0.12% Oral Rinse
- Generic name (nonproprietary)
- chlorhexidine gluconate 0.12% oral rinse
- Active ingredients
- Chlorhexidine gluconate — 1.2 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075006
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 62135-650_1935dfbf-e5dc-bc64-e063-6394a90ad2a1SPL ID 1935dfbf-e5dc-bc64-e063-6394a90ad2a1SPL set ID 923e22b1-0fa2-4a3c-900d-2d2eb63f841cRxCUI 834127UNII MOR84MUD8EUPC 0362135649470, 0362135649418
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N462135065024followed by a unit qualifier and the quantityPackage 62135-0650-24. 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 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 075006
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 | Chlorhexidine gluconate 1.2 mg/mL | SolutionOral | Chartwell RX, LLC | 62135-649 |
| Chlorhexidine Gluconate 0.12% Oral Rinse | Chlorhexidine gluconate 1.2 mg/mL | SolutionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-650 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.