Sulfamethoxazole and Trimethoprim (Page 7 of 7)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 800 mg/160 mg

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SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole and trimethoprim tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66267-816(NDC:65862-420)
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
DOCUSATE SODIUM
MAGNESIUM STEARATE
STARCH, CORN
SODIUM BENZOATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (White to Off-white) Score 2 pieces
Shape OVAL (Beveled Edge) Size 19mm
Flavor Imprint Code H;49
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66267-816-02 2 TABLET in 1 BOTTLE None
2 NDC:66267-816-04 4 TABLET in 1 BOTTLE None
3 NDC:66267-816-06 6 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090624 02/16/2010
Labeler — NuCare Pharmaceuticals, Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals, Inc. 010632300 repack (66267-816)

Revised: 01/2022 NuCare Pharmaceuticals, Inc.

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