Pantoprazole Sodium (Page 8 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

Pantoprazole sodium for injection is supplied in a single-dose vial as a sterile, freeze-dried, white to off-white, porous cake or powder for reconstitution containing 40 mg of pantoprazole.
Pantoprazole sodium for injection is available as follows:

40 mg per vial:
Single-dose Vials in a carton of 10 NDC 55150-202-10
Single-dose Vials in a carton of 25 NDC 55150-202-25
Storage and Handling

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from light.
The vial stopper is not made with natural rubber latex.

17 PATIENT COUNSELING INFORMATION

Adverse Reactions
Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with:

Drug Interactions
Instruct patients to inform their healthcare provider of any other medications they are currently taking, including rilpivirine-containing products [Contraindications (4)] and high dose methotrexate [Warnings and Precautions (5.14)].
Pregnancy
Advise a pregnant woman of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1)].
This product’s labeling may have been updated. For the most recent prescribing information, please visit www.auromedics.com or call 1-866-850-2876.
Distributed by:
AuroMedics Pharma LLC
279 Princeton-Hightstown Rd.
E. Windsor, NJ 08520
Manufactured by:
Eugia Pharma Specialities Limited
Hyderabad — 500032
India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 40 mg per vial — Container Label

Rx only NDC 55150-202-00
Pantoprazole
Sodium for Injection
40 mg per vial*
For Intravenous Infusion Only.
Sterile Single-dose Vial

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 40 mg per vial -- Container Label
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 40 mg per vial — Container-Carton (10 Vials)

Rx only NDC 55150-202-10
Pantoprazole
Sodium for Injection
40 mg per vial*
For Intravenous Infusion Only.
No filter required
Sterile 10 Single-dose Vials
AUROMEDICS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 40 mg per vial -- Container-Carton (10 Vials)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 40 mg per vial — Container-Carton (25 Vials)

Rx only NDC 55150-202-25
Pantoprazole
Sodium for Injection
40 mg per vial*
For Intravenous Infusion Only.
No filter required
Sterile 25 Single-dose Vials
AUROMEDICS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 40 mg per vial -- Container-Carton (25 Vials)
(click image for full-size original)

PANTOPRAZOLE SODIUM pantoprazole sodium injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55150-202
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANTOPRAZOLE SODIUM (PANTOPRAZOLE) PANTOPRAZOLE 40 mg
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55150-202-10 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (55150-202-00)
1 NDC:55150-202-00 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (55150-202-10)
2 NDC:55150-202-25 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (55150-202-00)
2 NDC:55150-202-00 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (55150-202-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205675 03/30/2016
Labeler — AuroMedics Pharma LLC (968961354)
Establishment
Name Address ID/FEI Operations
Eugia Pharma Specialities Limited 650498244 ANALYSIS (55150-202), MANUFACTURE (55150-202)

Revised: 05/2022 AuroMedics Pharma LLC

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.