Last Updated: November 13, 2026

Details for New Drug Application (NDA): 080581

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NDA 080581 describes PYRIDOXINE HYDROCHLORIDE, which is a drug marketed by Bel Mar, Dell Labs, Dr Reddys, Elkins Sinn, Epic Pharma Llc, Fresenius Kabi Usa, Luitpold, Mylan Institutional, and Watson Labs, and is included in ten NDAs. It is available from two suppliers. Additional details are available on the PYRIDOXINE HYDROCHLORIDE profile page.

The generic ingredient in PYRIDOXINE HYDROCHLORIDE is pyridoxine hydrochloride. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the pyridoxine hydrochloride profile page.

Summary for 080581

Tradename:	PYRIDOXINE HYDROCHLORIDE
Applicant:	Elkins Sinn
Ingredient:	pyridoxine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 080581

Vitamin B Complex

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	100MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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