Thiamine (Page 2 of 2)

HOW SUPPLIED:

Thiamine Hydrochloride Injection, USP is supplied as follows:

Product Code Unit of Sale
Strength Each
PRX1302 NDC 63323-013-26
Unit of 25
200 mg per 2 mL
(100 mg per mL)
NDC 63323-013-41
2 mL Multiple Dose Vial

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.

PREMIERProRx ® is a registered trademark of Premier Healthcare Alliance, L.P., used under license.
Manufactured by:
Fresenius Kabi
Lake Zurich, IL 60047
www.fresenius-kabi.com/us
451467A
Revised: October 2019
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PACKAGE LABEL – PRINCIPAL DISPLAY PANEL — Thiamine 2 mL Multiple Dose Vial Label

NDC 63323-013-41 PRX1302

Thiamine HCl

Injection, USP

200 mg per 2 mL

(100 mg per mL)

For IM or IV use.

Protect from light.

2 mL

Multiple Dose Vial Rx only

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL -- Thiamine 2 mL Multiple Dose Vial Label
(click image for full-size original)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Thiamine 2 mL Multiple Dose Vial Tray Label

NDC 63323-013-26 PRX1302

Thiamine HCl

Injection, USP

200 mg per 2 mL

(100 mg per mL)

For intramuscular or
intravenous use.

25 x 2 mL

Multiple Dose Vials

Rx only

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Thiamine 2 mL Multiple Dose Vial Tray Label
(click image for full-size original)
THIAMINE
thiamine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-013
Route of Administration INTRAVENOUS, INTRAMUSCULAR 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
CHLOROBUTANOL
MONOTHIOGLYCEROL
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-013-26 25 VIAL, MULTI-DOSE in 1 TRAY contains a VIAL, MULTI-DOSE (63323-013-41)
1 NDC:63323-013-41 2 mL in 1 VIAL, MULTI-DOSE This package is contained within the TRAY (63323-013-26)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA080556 09/01/2000
Labeler — Fresenius Kabi USA, LLC (608775388)
Establishment
Name Address ID/FEI Operations
Fresenius Kabi USA, LLC 840771732 ANALYSIS (63323-013), MANUFACTURE (63323-013)

Revised: 05/2020 Fresenius Kabi USA, LLC

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