Prescription drug · ANDA
Chlorhexidine Gluconate NDC 0116-6000
Chlorhexidine gluconate 1.2 mg/mL · Rinse · Oral · Xttrium Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0116-6000-04 | 00116600004 | 118 mL in 1 BOTTLE (0116-6000-04)Marketed from Nov 1, 2019 | |
| 0116-6000-16 | 00116600016 | 473 mL in 1 BOTTLE (0116-6000-16)Marketed from Apr 18, 2012 |
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
- Listing expires
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 0116-6000_34009d15-bb1d-9b7e-e063-6294a90ae5e3SPL ID 34009d15-bb1d-9b7e-e063-6294a90ae5e3SPL set ID 4a2c3c98-4e4e-1c9b-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
N400116600004followed by a unit qualifier and the quantityPackage 00116-6000-04. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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. | 0116-0175 |
| 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 |
| 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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