Chlorhexidine Gluconate NDC 0374-5080

NDC codes

FDA NDC Directory

Product NDC (as listed)0374-5080Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00374-5080Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
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: Nov 1, 2017
Listing expires: Dec 31, 2026
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

N400374508001 followed by a unit qualifier and the quantity

Package 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 Jan 2, 2019.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 074291

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 074291
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