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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 017768

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NDA 017768 describes HIBICLENS, which is a drug marketed by Molnlycke Hlth and is included in two NDAs. It is available from two suppliers. Additional details are available on the HIBICLENS profile page.

The generic ingredient in HIBICLENS is chlorhexidine gluconate. There are fifty-eight drug master file entries for this compound. Fifty-nine suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate profile page.

Summary for 017768

Tradename:	HIBICLENS
Applicant:	Molnlycke Hlth
Ingredient:	chlorhexidine gluconate
Patents:	0

Pharmacology for NDA: 017768

Physiological Effect	Decreased Cell Wall Integrity

Medical Subject Heading (MeSH) Categories for 017768

Anti-Infective Agents, Local
Disinfectants
Mouthwashes

Suppliers and Packaging for NDA: 017768

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HIBICLENS	chlorhexidine gluconate	SOLUTION;TOPICAL	017768	NDA	Molnlycke Health Care	0234-0575	0234-0575-40	118 mL in 1 BOTTLE (0234-0575-40)
HIBICLENS	chlorhexidine gluconate	SOLUTION;TOPICAL	017768	NDA	Molnlycke Health Care	0234-0575	0234-0575-41	118 mL in 1 BOTTLE, PUMP (0234-0575-41)

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	SOLUTION;TOPICAL			Strength	4%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 017768

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Molnlycke Hlth	HIBICLENS	chlorhexidine gluconate	SOLUTION;TOPICAL	017768-001	Approved Prior to Jan 1, 1982	3,855,140	⤷ Get Started Free
Molnlycke Hlth	HIBICLENS	chlorhexidine gluconate	SOLUTION;TOPICAL	017768-001	Approved Prior to Jan 1, 1982	3,960,745	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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