Prescription drug · ANDA
Chlorhexidine Gluconate NDC 0374-5080
Chlorhexidine gluconate 1.2 mg/mL · Rinse · Oral · Lyne Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0374-5080-01 | 00374508001 | 15 mL in 1 CUP, UNIT-DOSE (0374-5080-01)Marketed from Nov 1, 2017 | |
| 0374-5080-02 | 00374508002 | 473 mL in 1 BOTTLE (0374-5080-02)Marketed from Nov 1, 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)
- Chlorhexidine Gluconate
- Generic name (nonproprietary)
- chlorhexidine gluconate
- Active ingredients
- Chlorhexidine gluconate — 1.2 mg/mL
- Dosage form
- Rinse
- Route
- Oral
- Labeler
- Lyne Laboratories, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074291
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 0374-5080_7e7b458d-c301-5055-e053-2a91aa0aa93bSPL ID 7e7b458d-c301-5055-e053-2a91aa0aa93bSPL set ID 0348006f-b818-4465-a896-bc0d42294cf4RxCUI 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
N400374508001followed by a unit qualifier and the quantityPackage 00374-5080-01. 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 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 074291
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 |
|---|---|---|---|---|
| DASH Chlorhexidine Gluconate 0.12% Oral Rinsechlorhexidine gluconate 0.12% oral rinse | Chlorhexidine gluconate 1.2 mg/mL | LiquidOral | Natco Pharma USA LLC | 69339-138 |
| DASH Chlorhexidine Gluconate 0.12% Oral Rinsechlorhexidine gluconate 0.12% oral rinse | Chlorhexidine gluconate 1.2 mg/mL | LiquidOral | Cardinal Health 107, LLC | 55154-1980 |
| DASH Chlorhexidine Gluconate 0.12% Oral Rinsechlorhexidine gluconate 0.12% oral rinse | Chlorhexidine gluconate 1.2 mg/mL | LiquidOral | Cardinal Health 107, LLC | 55154-1981 |