NDC Code(s) : 10019-098-71, 10019-098-01
Packager : BAXTER HEALTHCARE CORPORATION

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CeftriaxoneCeftriaxone Sodium INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10019-098
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTRIAXONE SODIUM(UNII: 023Z5BR09K)
(CEFTRIAXONE - UNII:75J73V1629) 		CEFTRIAXONE SODIUM1 g
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10019-098-0110 in 1 BOX
1NDC:10019-098-711 in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065125 09/30/2003

PRINCIPAL DISPLAY PANEL

Ceftriaxone for Injection USP Vial LabelCeftriaxone for Injection USP Vial Label

NDC 10019-098-71

Ceftriaxone

for Injection USP

1 g

For I.M. or I.V. Use

Rx only Single Use Vial

Each vial contains sterile

ceftriaxone sodium USP

equivalent to ceftriaxone 1 g

 Mfd. for Amerinet Choice

by Lupin Limited

Mumbai 400 098 INDIA

For I.M. Administration: Reconstitute with 2.1 mL

1% Lidocaine Hydrochloride Injection (USP) or Sterile

Water for Injection (USP). Each 1 mL of solution contains

approximately 350 mg equivalent of ceftriaxone.

For I.V. Administration: See package insert.

USUAL DOSAGE: See package insert.

Storage Prior to Reconstitution:

Store powder at 20°-25°C (68°-77°F)

[See USP Controlled Room Temperature].

Storage After Reconstitution: See package insert.

PROTECT FROM LIGHT

Code No. MP/DRUGS/28/18/88

460-592-00

(01)00310019098715

Lot No:

Exp:

Ceftriaxone for Injection USP Vial LabelCarton Label

NDC 10019-098-01

Ceftriaxone for Injection USP

1 g

For Intramuscular or Intravenous Use

Rx only

Each vial contains sterile ceftriaxone sodium USP

equivalent to ceftriaxone 1 g

10 Vials Single Use Vials

Amerinet Choice

Manufactured for Amerinet Choice

St. Louis, MO 63146

by Lupin Limited

Mumbai 400 098 INDIA

Directions for Use:

For I.M. Administration: Reconstitute with 2.1 mL 1 %

Lidocaine Hydrochloride Injection (USP) or Sterile Water

for Injection (USP). Each 1 mL of solution contains

approximately 350 mg equivalent of ceftriaxone.

For I.V. Administration: Reconstitute with 9.6 mL of

an I.V. diluent specified in the accompanying package

insert. Each 1 mL of solution contains approximately

100 mg equivalent of ceftriaxone. Withdraw entire

contents and dilute to the desired concentration with

the appropriate I.V. diluent.

USUAL DOSAGE:

For dosage recommendations and other important

prescribing information, read accompanying insert.

Storage Prior to Reconstitution:

Store powder at 20°-25°C (68°-77°F) [See USP

Controlled Room Temperature].

Storage After Reconstitution: See package insert.

PROTECT FROM LIGHT