Prescription drug · ANDA
Chlorhexidine Gluconate 0.12% Oral Rinse (Chlorhexidine gluconate) NDC 53462-003
Chlorhexidine gluconate 1.2 mg/mL · Liquid · Buccal · Sage Products LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53462-003-15 | 5346200031553462000315 | 15 mL in 1 BOTTLE (53462-003-15)Marketed from Jan 20, 2014 |
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
- Active ingredients
- Chlorhexidine gluconate — 1.2 mg/mL
- Dosage form
- Liquid
- Route
- Buccal
- Labeler
- Sage Products LLCNDC labeler code 53462
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077789
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 53462-003_41ae4422-c96e-9918-e063-6394a90ad0a3SPL ID 41ae4422-c96e-9918-e063-6394a90ad0a3SPL set ID 3c754532-d9a5-f876-00c4-05a4c9b21efaRxCUI 834127UNII MOR84MUD8EUPC 0353462003158
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
N453462000315followed by a unit qualifier and the quantityPackage 53462-0003-15. 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.
About NDC 53462-003
- What is NDC 53462-003?
- 53462-003 is the product NDC for Chlorhexidine Gluconate 0.12% Oral Rinse, Chlorhexidine gluconate 1.2 mg/mL liquid, listed with the FDA by Sage Products LLC. 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 (Chlorhexidine gluconate).
- What is the active ingredient?
- Chlorhexidine gluconate.
- Who is the labeler?
- Sage Products LLC, NDC labeler code 53462. 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?
- 5 other product NDCs are listed under this name. See all Chlorhexidine Gluconate 0.12% Oral Rinse 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 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 | Chlorhexidine gluconate 1.2 mg/mL | SolutionDental | American Health Packaging | 60687-714 | 60687-0714-1660687-0714-64 |
| Chlorhexidine Gluconate 0.12% Oral Rinsechlorhexidine gluconate | Chlorhexidine gluconate 1.2 [iU]/mL | LiquidBuccal | Xttrium Laboratories, Inc. | 0116-0003 | 00116-0003-15 |
| Chlorhexidine Gluconate 0.12% Oral Rinse | Chlorhexidine gluconate 1.2 mg/mL | SolutionOral | Chartwell RX, LLC | 62135-649 | 62135-0649-4162135-0649-47 |
| Chlorhexidine Gluconate 0.12% Oral Rinse | Chlorhexidine gluconate 1.2 mg/mL | SolutionOral | Chartwell RX, LLC | 62135-650 | 62135-0650-24 |
| Chlorhexidine Gluconate 0.12% Oral Rinse | Chlorhexidine gluconate 1.2 mg/mL | SolutionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-650 | 68999-0650-24 |
Other NDCs under ANDA 077789
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 |
|---|---|---|---|---|
| Acclean Chlorhexidine Gluconate 0.12% Oral Rinsechlorhexidine gluconate 0.12% oral rinse | Chlorhexidine gluconate 1.2 mg/mL | LiquidOral | Xttrium Laboratories, Inc. | 0116-4075 |
| Acclean Chlorhexidine Gluconate 0.12% Oral Rinsechlorhexidine gluconate 0.12% oral rinse | Chlorhexidine gluconate 1.2 mg/mL | LiquidOral | Xttrium Laboratories, Inc. | 0116-6720 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate .12 mg/mL | LiquidOral | Xttrium Laboratories, Inc. | 0116-0101 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Xttrium Laboratories, Inc. | 0116-0175 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Xttrium Laboratories, Inc. | 0116-0301 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Xttrium Laboratories, Inc. | 0116-1999 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Xttrium Laboratories, Inc. | 0116-2001 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Xttrium Laboratories, Inc. | 0116-6000 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseDental | Major Pharmaceuticals | 0904-7035 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Atlantic Biologicals Corps. | 17856-2001 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | ATLANTIC BIOLOGICALS CORP. | 17856-2002 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | A-S Medication Solutions | 50090-0722 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Medline Industries, LP | 53329-301 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Den-mat Holdings, Llc | 59883-175 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Proficient Rx LP | 63187-685 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Darby Dental Supply, LLC | 66467-2560 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Benco Dental | 66975-600 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | NuCare Pharmaceuticals,Inc. | 68071-1837 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Preferred Pharmaceuticals, Inc. | 68788-9546 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | REMEDYREPACK INC. | 70518-4494 |
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