THIAMINE HYDROCHLORIDE (Page 2 of 2)

How Supplied

Thiamine Hydrochloride Injection, USP, 200 mg/2 mL (100 mg/mL), is available in:

NDC 67457-196-02
2 mL (200 mg) multiple-dose vial, packaged 25 vials per carton.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Protect from light.

Use only if solution is clear and seal intact.

Preservative Free.

Manufactured for:
Mylan Institutional LLC
Morgantown, WV 26505 U.S.A.

Manufactured by:
Mylan Institutional
Galway, Ireland

0941L101

Revised: 4/2021
MI:THIAIJ:R4

Sample Package Label

//medlibrary.org/lib/images-rx/thiamine-hydrochloride-6/label1-300x300.jpg
(click image for full-size original)

THIAMINE HYDROCHLORIDE
thiamine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52584-196(NDC:67457-196)
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE HYDROCHLORIDE 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MONOTHIOGLYCEROL 5 mg in 1 mL
WATER
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52584-196-00 1 VIAL, MULTI-DOSE in 1 BAG contains a VIAL, MULTI-DOSE
1 2 mL in 1 VIAL, MULTI-DOSE This package is contained within the BAG (52584-196-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091623 08/21/2013
Labeler — General Injectables & Vaccines, Inc (108250663)

Revised: 04/2022 General Injectables & Vaccines, Inc

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.