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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 080618

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NDA 080618 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 are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pyridoxine hydrochloride profile page.

Summary for 080618

Tradename:	PYRIDOXINE HYDROCHLORIDE
Applicant:	Fresenius Kabi Usa
Ingredient:	pyridoxine hydrochloride
Patents:	0

Pharmacology for NDA: 080618

Ingredient-type	Analogs/Derivatives Vitamin B 6

Medical Subject Heading (MeSH) Categories for 080618

Vitamin B Complex

Suppliers and Packaging for NDA: 080618

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PYRIDOXINE HYDROCHLORIDE	pyridoxine hydrochloride	INJECTABLE;INJECTION	080618	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1410	51662-1410-1	1 mL in 1 VIAL (51662-1410-1)
PYRIDOXINE HYDROCHLORIDE	pyridoxine hydrochloride	INJECTABLE;INJECTION	080618	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1410	51662-1410-3	25 POUCH in 1 CASE (51662-1410-3) / 1 VIAL in 1 POUCH (51662-1410-2) / 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	100MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

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