NDC Code(s) : 50090-0010-0, 50090-0010-2
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0010(NDC:0603-5781)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFAMETHOXAZOLE(UNII: JE42381TNV)
(SULFAMETHOXAZOLE - UNII:JE42381TNV) 		SULFAMETHOXAZOLE800 mg
TRIMETHOPRIM(UNII: AN164J8Y0X)
(TRIMETHOPRIM - UNII:AN164J8Y0X) 		TRIMETHOPRIM160 mg
Inactive Ingredients
Ingredient Name Strength
DOCUSATE SODIUM(UNII: F05Q2T2JA0)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color WHITE (to off white) Score 2 pieces
Shape OVAL Size 19 mm
Flavor Imprint Code 5898;V
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-0010-0 10 in 1 BOTTLE Type 0: Not a Combination Product01/01/2012
2NDC:50090-0010-2 20 in 1 BOTTLE Type 0: Not a Combination Product28/11/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078060 01/25/2007 09/30/2016

PRINCIPAL DISPLAY PANEL

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