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Last Updated: March 18, 2026

Details for New Drug Application (NDA): 020251

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NDA 020251 describes ZANTAC 25, which is a drug marketed by Glaxo Grp Ltd and is included in one NDA. Additional details are available on the ZANTAC 25 profile page.

The generic ingredient in ZANTAC 25 is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for 020251

Tradename:	ZANTAC 25
Applicant:	Glaxo Grp Ltd
Ingredient:	ranitidine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EFFERVESCENT;ORAL			Strength	EQ 150MG BASE
Approval Date:	Mar 31, 1994	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GRANULE, EFFERVESCENT;ORAL			Strength	EQ 150MG BASE/PACKET
Approval Date:	Mar 31, 1994	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EFFERVESCENT;ORAL			Strength	EQ 25MG BASE
Approval Date:	Apr 1, 2004	TE:		RLD:	No

Expired US Patents for NDA 020251

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	ZANTAC 150	ranitidine hydrochloride	GRANULE, EFFERVESCENT;ORAL	020251-002	Mar 31, 1994	⤷ Get Started Free	⤷ Get Started Free
Glaxo Grp Ltd	ZANTAC 150	ranitidine hydrochloride	TABLET, EFFERVESCENT;ORAL	020251-001	Mar 31, 1994	⤷ Get Started Free	⤷ Get Started Free
Glaxo Grp Ltd	ZANTAC 150	ranitidine hydrochloride	TABLET, EFFERVESCENT;ORAL	020251-001	Mar 31, 1994	⤷ Get Started Free	⤷ Get Started Free
Glaxo Grp Ltd	ZANTAC 150	ranitidine hydrochloride	TABLET, EFFERVESCENT;ORAL	020251-001	Mar 31, 1994	⤷ Get Started Free	⤷ Get Started Free
Glaxo Grp Ltd	ZANTAC 150	ranitidine hydrochloride	GRANULE, EFFERVESCENT;ORAL	020251-002	Mar 31, 1994	⤷ Get Started Free	⤷ Get Started Free
Glaxo Grp Ltd	ZANTAC 150	ranitidine hydrochloride	GRANULE, EFFERVESCENT;ORAL	020251-002	Mar 31, 1994	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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