NDC Code(s) : 24236-012-08
Packager : REMEDYREPACK INC.

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:24236-012(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(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:24236-012-0810 in 1 VIAL Type 0: Not a Combination Product27/02/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078060 02/27/2013 09/23/2015

PRINCIPAL DISPLAY PANEL

DRUG: Sulfamethoxazole and Trimethoprim

GENERIC: Sulfamethoxazole and Trimethoprim

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 24236-012-08

COLOR: white

SHAPE: OVAL

SCORE: Two even pieces

SIZE: 19 mm

IMPRINT: 5898;V

PACKAGING: 10 in 1 VIAL

ACTIVE INGREDIENT(S):

  • SULFAMETHOXAZOLE 800mg in 1
  • TRIMETHOPRIM 160mg in 1

INACTIVE INGREDIENT(S):

  • DOCUSATE SODIUM
  • SODIUM BENZOATE
  • STARCH, CORN
  • MAGNESIUM STEARATE
  • POVIDONE
  • SODIUM STARCH GLYCOLATE TYPE A POTATO

/xml/08110c7d-7573-4bc9-ae1b-30893b76009d/Remedy_Label.jpg