Ampicillin (Page 4 of 4)

HOW SUPPLIED

Ampicillin for Injection, USP, is supplied as follows:

NDC	Ampicillin for Injection, USP	Package Factor
25021-134-10	250 mg per vial	10 vials per carton
25021-135-10	500 mg per vial	10 vials per carton
25021-136-10	1 gram per vial	10 vials per carton
25021-137-20	2 grams per vial	10 vials per carton

Each vial contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin per vial.

Storage Conditions
Store dry powder at 20˚ to 25˚C (68˚ to 77˚F). [See USP Controlled Room Temperature.]

Sterile, Nonpyrogenic, Preservative-free.
The container closure is not made with natural rubber latex.

Clinitest is a registered trademark of Miles, Inc.
Clinistix is a registered trademark of Bayer Corporation.
Tes-Tape is a registered trademark of Eli Lilly Company.

SAGENT^®
Mfd. for SAGENT Pharmaceuticals
Schaumburg, IL 60195 (USA)
Made in Romania©2018 Sagent Pharmaceuticals, Inc.

Revised: April 2018

SAGENT Pharmaceuticals^®

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label

NDC 25021-134-10

Rx only

Ampicillin for Injection, USP

250 mg* per vial

For Intravenous or Intramuscular Use

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label

NDC 25021-135-10

Rx only

Ampicillin for Injection, USP

500 mg* per vial

For Intravenous or Intramuscular Use

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label

NDC 25021-136-10

Rx only

Ampicillin for Injection, USP

1 gram* per vial

For Intravenous or Intramuscular Use

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label

NDC 25021-137-20

Rx only

Ampicillin for Injection, USP

2 grams* per vial

For Intravenous Use

AMPICILLIN ampicillin injection, powder, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25021-134 Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ampicillin sodium (ampicillin) ampicillin 250 mg

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:25021-134-10 10 VIAL in 1 CARTON contains a VIAL 1 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL This package is contained within the CARTON (25021-134-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090354 07/01/2014 04/30/2021

AMPICILLIN ampicillin injection, powder, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25021-135 Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ampicillin sodium (ampicillin) ampicillin 500 mg

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:25021-135-10 10 VIAL in 1 CARTON contains a VIAL 1 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL This package is contained within the CARTON (25021-135-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090354 07/01/2014 03/31/2022

AMPICILLIN ampicillin injection, powder, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25021-136 Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ampicillin sodium (ampicillin) ampicillin 1 g

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:25021-136-10 10 VIAL in 1 CARTON contains a VIAL 1 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL This package is contained within the CARTON (25021-136-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090354 07/01/2014

AMPICILLIN ampicillin injection, powder, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25021-137 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ampicillin sodium (ampicillin) ampicillin 2 g

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:25021-137-20 10 VIAL in 1 CARTON contains a VIAL 1 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL This package is contained within the CARTON (25021-137-20)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090354 07/01/2014

Labeler — Sagent Pharmaceuticals (796852890)

Revised: 05/2021 Sagent Pharmaceuticals