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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 075561

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NDA 075561 describes CHLORHEXIDINE GLUCONATE, which is a drug marketed by Sage Prods, Bajaj, Chartwell Rx, Lyne, Pharm Assoc, Pharmobedient, Sciegen Pharms, Becton Dickinson, and Kendall Il, and is included in ten NDAs. It is available from thirty-two suppliers. There are two 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 075561

Tradename:	CHLORHEXIDINE GLUCONATE
Applicant:	Bajaj
Ingredient:	chlorhexidine gluconate
Patents:	0

Pharmacology for NDA: 075561

Physiological Effect	Decreased Cell Wall Integrity

Medical Subject Heading (MeSH) Categories for 075561

Anti-Infective Agents, Local
Disinfectants
Mouthwashes

Suppliers and Packaging for NDA: 075561

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORHEXIDINE GLUCONATE	chlorhexidine gluconate	SOLUTION;DENTAL	075561	ANDA	Rising Pharma Holdings, Inc.	16571-128	16571-128-48	473 mL in 1 BOTTLE (16571-128-48)
CHLORHEXIDINE GLUCONATE	chlorhexidine gluconate	SOLUTION;DENTAL	075561	ANDA	Rising Pharma Holdings, Inc.	16571-128	16571-128-52	100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (16571-128-52) / 15 mL in 1 CUP, UNIT-DOSE (16571-128-15)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;DENTAL			Strength	0.12%
Approval Date:	Nov 14, 2000	TE:	AT	RLD:	No

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