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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 218698

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NDA 218698 describes LOPRESSOR, which is a drug marketed by Novartis, Rubicon Research, Validus Pharms, and Xtm Consulting, and is included in six NDAs. It is available from two suppliers. Additional details are available on the LOPRESSOR profile page.

The generic ingredient in LOPRESSOR is hydrochlorothiazide; metoprolol tartrate. There are thirty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol tartrate profile page.

Summary for 218698

Tradename:	LOPRESSOR
Applicant:	Xtm Consulting
Ingredient:	metoprolol tartrate
Patents:	0

Pharmacology for NDA: 218698

Mechanism of Action	Adrenergic beta-Antagonists

Suppliers and Packaging for NDA: 218698

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LOPRESSOR	metoprolol tartrate	TABLET;ORAL	218698	NDA	VALIDUS PHARMACEUTICALS LLC	30698-460	30698-460-03	30 TABLET in 1 BOTTLE (30698-460-03)
LOPRESSOR	metoprolol tartrate	TABLET;ORAL	218698	NDA	VALIDUS PHARMACEUTICALS LLC	30698-460	30698-460-10	1000 TABLET in 1 BOTTLE (30698-460-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG
Approval Date:	Aug 28, 2025	TE:		RLD:	Yes

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