NDC Code(s) : 51079-128-01, 51079-128-20, 51079-128-08
Packager : Mylan Institutional 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:51079-128(NDC:53489-146)
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)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 19 mm
Flavor Imprint Code MP;85
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51079-128-20100 in 1 BOX, UNIT-DOSE 10/02/2004
1NDC:51079-128-011 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:51079-128-0880 in 1 BOX, UNIT-DOSE 15/01/2015
2NDC:51079-128-011 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071017 02/10/2004 01/31/2018

PRINCIPAL DISPLAY PANEL

NDC 51079-128-08

Sulfamethoxazole
and Trimethoprim
Tablets, USP
800 mg/160 mg
DOUBLE STRENGTH

Each tablet contains:
Sulfamethoxzole, USP . . . . 800 mg
Trimethoprim, USP . . . . 160 mg

Usual Dosage: See accompanying
prescribing information.

Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]
Protect from light.

Tablet debossed: MP85

Manufactured by:
Mutual Pharmaceutical Company, Inc.
Philadelphia, PA 19124

Manufactured for:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512

Rx only

S-12145 R1

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Sulfamethoxazole and Trimethoprin 800 mg/160 mg Tablets Unit Carton Label
Sulfamethoxazole and Trimethoprin 800 mg/160 mg Tablets Unit Carton Label