Ceftriaxone (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — Pharmacy Bulk Package — Ceftriaxone bag label

NDC 66288-6100-1 SMAR_x TPAK

CEFTRIAXONE FOR INJECTION, USP

PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION

100 grams [ONE HUNDRED GRAMS] per Pharmacy Bulk Package Bag

FOR INTRAVENOUS USE ONLY

NOT TO BE DISPENSED AS A UNIT

Rx Only

Sterile, Nonpyrogenic, Preservative-Free

Each 100 gram Pharmacy Bulk Package contains sterile ceftriaxone sodium equivalent to 100 grams of ceftriaxone. The sodium content is 83 mg (3.6 mEq) per gram of ceftriaxone activity.

Use this formulation only in patients who require a 1 gram dose. Contains 100 doses (1 gram per dose). See package insert. USUAL DOSAGE: See package insert.

Prior to reconstitution, store dry powder at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] Protect from light. After reconstitution, dilute and use promptly. DISCARD BAG WITHIN 4 HOURS AFTER INITIAL ENTRY. See package insert for full information.

THIS PHARMACY BULK PACKAGE IS INTENDED FOR PREPARING MANY SINGLE DOSES IN A PHARMACY ADMIXTURE PROGRAM.

Approximate Concentration	Amount of Sterile Water for Injection
1 gram/10 mL	950 mL

See package insert for detailed reconstitution, final dilution, and administration instructions.

PROTECT FROM LIGHT. THE INNER BAG SHOULD BE RETAINED IN THE OUTER BAG UNTIL TIME OF USE.

SmartPak^® system components are not made with natural rubber latex.

Manufactured for
SAMSON
MEDICAL TECHNOLOGIES L.L.C.Cherry Hill, NJ 08003,

Date entered
Time of entry
Discard within 4 hours

CEFTRIAXONE ceftriaxone sodium injection, powder, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66288-6100 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEFTRIAXONE SODIUM (CEFTRIAXONE) CEFTRIAXONE 100 g

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:66288-6100-1 1 INJECTION, POWDER, FOR SOLUTION in 1 BAG None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090057 06/30/2014

Labeler — Samson Medical Technologies, LLC (102837429)

Registrant — Samson Medical Technologies, LLC (102837429)

Establishment
Name	Address	ID/FEI	Operations
ACS Dobfar S.p.A.		429243025	manufacture (66288-6100)

Revised: 01/2023 Samson Medical Technologies, LLC