Sulfamethoxazole and Trimethoprim (Page 5 of 5)


NDC:64725-0146-1 in a BOTTLE of 100 TABLETS

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room Temperature]



  1. Kremers P, Duvivier J, Heusghem C. Pharmacokinetic Studies of Co-Trimoxazole in Man after Single and Repeated Doses. . Feb-Mar 1974; 14:112–117. J Clin Pharmacol
  2. Kaplan SA, et al. Pharmacokinetic Profile of Trimethoprim-Sulfamethoxazole in Man. . Nov 1973; 128 (Suppl): S547–S555. J Infect Dis
  3. Varoquaux O, et al. Pharmacokinetics of the trimethoprim-sulfamethoxazole combination in the elderly. . 1985;20:575–581. Br J Clin Pharmacol
  4. Rudoy RC, Nelson JD, Haltalin KC. . May 1974;5:439–443. Antimicrobial Agents Chemother
  5. Clinical and Laboratory Standards Institute. . CLSI document M07–A9, CLSI, Wayne, PA, 2012. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – 9 ed th
  6. Safrin S, Lee BL, Sande MA. Adjunctive folinic acid with trimethoprim-sulfamethoxazole for pneumonia in AIDS patients is associated with an increased risk of therapeutic failure and death. . 1994 Oct;170(4):912-7. Pneumocystis carinii J Infect Dis
  7. Hardy DW, et al. A controlled trial of trimethoprim-sulfamethoxazole or aerosolized pentamidine for secondary prophylaxis of pneumonia in patients with the acquired immunodeficiency syndrome. . 1992; 327: 1842–1848. Pneumocystis carinii N Engl J Med
  8. Marinella Mark A. 1999. Trimethoprim-induced hyperkalemia: An analysis of reported cases. . 45:209–212. Gerontol
  9. Margassery, S. and B. Bastani. 2002. Life threatening hyperkalemia and acidosis secondary to trimethoprim-sulfamethoxazole treatment. . 14:410–414. J. Nephrol
  10. Brumfitt W, Pursell R. Trimethoprim/Sulfamethoxazole in the Treatment of Bacteriuria in Women. . Nov 1973; 128 (Suppl):S657–S663. J Infect Dis
  11. Masur H. Prevention and treatment of pneumonia. . 1992; 327: 1853–1880. Pneumocystis N Engl J Med
  12. Recommendations for prophylaxis against pneumonia for adults and adolescents infected with human immunodeficiency virus. 1992; 41(RR-4):1–11. Pneumocystis carinii MMWR.
  13. CDC Guidelines for prophylaxis against pneumonia for children infected with human immunodeficiency virus. . 1991; 40(RR-2):1–13. Pneumocystis carinii MMWR
  14. Clinical and Laboratory Standards Institute. . CLSI document M02–A11, CLSI, Wayne, PA, 2012. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard – 11 ed th
  15. Clinical and Laboratory Standards Institute (CLSI). , CLSI document M100–S23. CLSI document M100–S23, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2013. Performance Standards for Antimicrobial Susceptibility Testing; Twenty-third Informational Supplement

Manufactured by: MUTUAL PHARMACEUTICAL COMPANY, INC. Philadelphia, PA 19124 USA

Rev 05, July 2013

Label Image
(click image for full-size original)
sulfamethoxazole and trimethoprim tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64725-0146(NDC:53489-146)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sulfamethoxazole (Sulfamethoxazole) Sulfamethoxazole 800 mg
Trimethoprim (Trimethoprim) Trimethoprim 160 mg
Inactive Ingredients
Ingredient Name Strength
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 19mm
Flavor Imprint Code MP;85
# Item Code Package Description Multilevel Packaging
1 NDC:64725-0146-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071017 08/25/1986
Labeler — TYA Pharmaceuticals (938389038)
Registrant — TYA Pharmaceuticals (938389038)
Name Address ID/FEI Operations
TYA Pharmaceuticals 938389038 RELABEL (64725-0146), REPACK (64725-0146)

Revised: 08/2013 TYA Pharmaceuticals

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