Ceftriaxone (Page 7 of 7)

REFERENCES

  1. National Committee for Clinical Laboratory Standards, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard-Fifth Edition. NCCLS document M7-A5 (ISBN 1-56238-309-9). NCCLS, Wayne, PA 19087-1898, 2000.
  2. National Committee for Clinical Laboratory Standards, Supplemental Tables. NCCLS document M100-S10(M7) (ISBN 1-56238-309-9). NCCLS, Wayne, PA 19087-1898, 2000.
  3. National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard-Seventh Edition. NCCLS document M2-A7 (ISBN 1-56238-393-0). NCCLS, Wayne, PA 19087-1898, 2000.
  4. National Committee for Clinical Laboratory Standards, Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Fourth Edition. NCCLS document M11-A4 (ISBN 1-56238-210-1). NCCLS, Wayne, PA 19087 1898, 1997.
  5. Barnett ED, Teele DW, Klein JO, et al. Comparison of Ceftriaxone and Trimethoprim-Sulfamethoxazole for Acute Otitis Media. Pediatrics. Vol. 99, No.1, January 1997.

Manufactured by: GlaxoSmithKline Manufacturing S.p.A. — Verona — Italy

Distributed by: West-Ward Injectables — Eatontown — New Jersey — USA

Issued May 2009

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL
(click image for full-size original)
PRINCIPAL DISPLAY PANEL
(click image for full-size original)
CEFTRIAXONE ceftriaxone injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9768
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTRIAXONE SODIUM (CEFTRIAXONE) CEFTRIAXONE 10 g in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9768-46 1 VIAL in 1 BOX contains a VIAL (0143-9768-01)
1 NDC:0143-9768-01 100 mL in 1 VIAL This package is contained within the BOX (0143-9768-46)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065328 08/06/2009
Labeler — Hikma Pharmaceuticals USA Inc. (001230762)

Revised: 12/2019 Hikma Pharmaceuticals USA Inc.

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