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

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