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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 074522

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NDA 074522 describes CHLORHEXIDINE GLUCONATE, which is a drug marketed by Sage Prods, Bajaj, Chartwell Rx, Lyne, Pharm Assoc, Pharmobedient, Sciegen Pharms Inc, Becton Dickinson, and Kendall Il, and is included in ten NDAs. It is available from thirty-two suppliers. There are three patents protecting this drug. Additional details are available on the CHLORHEXIDINE GLUCONATE profile page.

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

Summary for 074522

Tradename:	CHLORHEXIDINE GLUCONATE
Applicant:	Pharm Assoc
Ingredient:	chlorhexidine gluconate
Patents:	0

Pharmacology for NDA: 074522

Physiological Effect	Decreased Cell Wall Integrity

Medical Subject Heading (MeSH) Categories for 074522

Anti-Infective Agents, Local
Disinfectants
Mouthwashes

Suppliers and Packaging for NDA: 074522

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORHEXIDINE GLUCONATE	chlorhexidine gluconate	SOLUTION;DENTAL	074522	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-0893	0121-0893-00	10 TRAY in 1 CASE (0121-0893-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-0893-15)
CHLORHEXIDINE GLUCONATE	chlorhexidine gluconate	SOLUTION;DENTAL	074522	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-0893	0121-0893-16	473 mL in 1 BOTTLE (0121-0893-16)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;DENTAL			Strength	0.12%
Approval Date:	Dec 15, 1995	TE:	AT	RLD:	No

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