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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 021532

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NDA 021532 describes BENICAR HCT, which is a drug marketed by Cosette and is included in one NDA. It is available from two suppliers. Additional details are available on the BENICAR HCT profile page.

The generic ingredient in BENICAR HCT is hydrochlorothiazide; olmesartan medoxomil. There are thirty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.

Summary for 021532

Tradename:	BENICAR HCT
Applicant:	Cosette
Ingredient:	hydrochlorothiazide; olmesartan medoxomil
Patents:	0

Pharmacology for NDA: 021532

Mechanism of Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased Diuresis

Suppliers and Packaging for NDA: 021532

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532	NDA	Cosette Pharmaceuticals, Inc.	0713-0863	0713-0863-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0863-30)
BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532	NDA	Cosette Pharmaceuticals, Inc.	0713-0864	0713-0864-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0864-30)

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG;20MG
Approval Date:	Jun 5, 2003	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG;40MG
Approval Date:	Jun 5, 2003	TE:	AB	RLD:	Yes

Profile for product number 005

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG;40MG
Approval Date:	Jun 5, 2003	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021532

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-002	Jun 5, 2003	5,616,599*PED	⤷ Get Started Free
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-005	Jun 5, 2003	6,878,703*PED	⤷ Get Started Free
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-003	Jun 5, 2003	6,878,703*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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