Prescription drug · ANDA
NUPRO Chlorhexidine Gluconate (Chlorhexidine gluconate) NDC 0116-0800
Chlorhexidine gluconate 1.2 mg/mL · Rinse · Oral · Xttrium Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0116-0800-16 | 0011608001600116080016 | 473 mL in 1 BOTTLE (0116-0800-16)Marketed from Jan 17, 2017 |
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)
- NUPRO Chlorhexidine Gluconate
- Generic name (nonproprietary)
- chlorhexidine gluconate
- Active ingredients
- Chlorhexidine gluconate — 1.2 mg/mL
- Dosage form
- Rinse
- Route
- Oral
- Labeler
- Xttrium Laboratories, Inc.NDC labeler code 0116
- 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 0116-0800_34009d15-bb1b-9b7e-e063-6294a90ae5e3SPL ID 34009d15-bb1b-9b7e-e063-6294a90ae5e3SPL set ID 4a3b87bc-d913-6c88-e054-00144ff8d46cRxCUI 834127, 1869723UNII 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
N400116080016followed by a unit qualifier and the quantityPackage 00116-0800-16. 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.
About NDC 0116-0800
- What is NDC 0116-0800?
- 0116-0800 is the product NDC for NUPRO Chlorhexidine Gluconate (chlorhexidine gluconate), Chlorhexidine gluconate 1.2 mg/mL rinse, listed with the FDA by Xttrium Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- NUPRO Chlorhexidine Gluconate (Chlorhexidine gluconate).
- What is the active ingredient?
- Chlorhexidine gluconate.
- Who is the labeler?
- Xttrium Laboratories, Inc., NDC labeler code 0116. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for NUPRO Chlorhexidine Gluconate?
- 1 other product NDC are listed under this name. See all NUPRO 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 NUPRO 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) |
|---|---|---|---|---|---|
| NUPRO Chlorhexidine Gluconatechlorhexidine gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Dentsply LLC. Professional Division Trading as "DENTSPLY Professional" | 65222-800 | 65222-0800-16 |
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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