Prescription drug · ANDA
Chlorhexidine Gluconate NDC 0116-0175
Chlorhexidine gluconate 1.2 mg/mL · Rinse · Oral · Xttrium Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0116-0175-16 | 00116017516 | 473 mL in 1 BOTTLE, PLASTIC (0116-0175-16)Marketed from Jun 18, 2009 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Oral
- Labeler
- Xttrium Laboratories, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077789
- Marketing start
- Marketing end
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 0116-0175_50749dac-78e5-2cec-e063-6394a90ac90cSPL ID 50749dac-78e5-2cec-e063-6394a90ac90cSPL set ID 4a3a4cfe-88e0-0a10-e054-00144ff88e88RxCUI 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400116017516followed by a unit qualifier and the quantityPackage 00116-0175-16. 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 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 |
|---|---|---|---|---|
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Den-mat Holdings, Llc | 59883-175 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Xttrium Laboratories, Inc. | 0116-0301 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | NuCare Pharmaceuticals,Inc. | 68071-1837 |
| 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 |
| Acclean Chlorhexidine Gluconate 0.12% Oral Rinsechlorhexidine gluconate 0.12% oral rinse | Chlorhexidine gluconate 1.2 mg/mL | LiquidOral | Henry Schein, Inc. | 0404-4075 |
| Chlorhexidine Gluconate 0.12% Oral Rinsechlorhexidine gluconate | Chlorhexidine gluconate 1.2 mg/mL | LiquidBuccal | Sage Products LLC | 53462-003 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Proficient Rx LP | 63187-685 |
| Major Oral Rinse0.12% chlorhexidine gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Cardinal Health 107, LLC | 55154-3573 |
| NUPRO Chlorhexidine Gluconatechlorhexidine gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Xttrium Laboratories, Inc. | 0116-0800 |
| Major Oral Rinse0.12% chlorhexidine gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Cardinal Health 107, LLC | 55154-3574 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | REMEDYREPACK INC. | 70518-4494 |
| Acclean Chlorhexidine Gluconate 0.12% Oral Rinsechlorhexidine gluconate 0.12% oral rinse | Chlorhexidine gluconate 1.2 mg/mL | LiquidOral | Xttrium Laboratories, Inc. | 0116-4075 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | A-S Medication Solutions | 50090-0722 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Xttrium Laboratories, Inc. | 0116-6000 |
| Acclean Chlorhexidine Gluconate 0.12% Oral Rinsechlorhexidine gluconate 0.12% oral rinse | Chlorhexidine gluconate 1.2 mg/mL | LiquidOral | Xttrium Laboratories, Inc. | 0116-6720 |
| Sky Oral Rinsechlorhexidine gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | McKesson | 63739-052 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Benco Dental | 66975-600 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Medline Industries, LP | 53329-301 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseDental | Major Pharmaceuticals | 0904-7035 |
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