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Drug Product Composition: Trimethoprim Sulfamethoxazole

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USFDA APPLICATION NUMBER - 17377 / DOSAGE - TABLET;ORAL - 800MG;160MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFAMETHOXAZOLE(UNII: JE42381TNV)
(SULFAMETHOXAZOLE - UNII:JE42381TNV)
SULFAMETHOXAZOLE400mg | 800mg
TRIMETHOPRIM(UNII: AN164J8Y0X)
(TRIMETHOPRIM - UNII:AN164J8Y0X)
TRIMETHOPRIM80mg | 160mg

Inactive Ingredients

Ingredient Name
REMEDYREPACK INC.
Cardinal Health
A-S Medication Solutions
A-S Medication Solutions LLC
AR Scientific, Inc.
Aurobindo Pharma Limited
Bryant Ranch Prepack
Clinical Solutions Wholesale
Glenmark Generics Inc. USA
KAISER FOUNDATION HOSPITALS
LUCID PHARMA LLC
McKesson Corporation dba SKY Packaging
Mylan Institutional Inc.
Preferred Pharmaceuticals, Inc
Proficient Rx LP
Qualitest Pharmaceuticals
REMEDYREPACK INC.
Sun Pharmaceutical Industries, Inc
Teva Pharmaceuticals USA, Inc.
American Health Packaging
Avera McKennan Hospital
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Golden State Medical Supply, Inc.
Lake Erie Medical DBA QualityL Care Products LC
Lake Erie Medical Quality Care Products LLC
McKesson Contract Packaging
NCS HealthCare of KY, Inc dba Vangard Labs
PD-Rx Pharmaceuticals, Inc.
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals, Inc.
Unit Dose Services
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)                              
CROSPOVIDONE, UNSPECIFIED(2S7830E561)                              
DOCUSATE SODIUM(F05Q2T2JA0)              
FD&C BLUE NO. 2(L06K8R7DQK)                              
FD&C RED NO. 40(WZB9127XOA)                              
FD&C YELLOW NO. 6(H77VEI93A8)                              
HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N)                              
HYPROMELLOSES(3NXW29V3WO)                              
LACTOSE MONOHYDRATE(EWQ57Q8I5X)                             
MAGNESIUM STEARATE(70097M6I30) 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)                              
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)                              
POVIDONE(FZ989GH94E)                        
POVIDONE, UNSPECIFIED(FZ989GH94E)                         
POVIDONES(FZ989GH94E)                        
SILICON DIOXIDE(ETJ7Z6XBU4)                              
SODIUM BENZOATE(OJ245FE5EU)              
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)  
STARCH, CORN(O8232NY3SJ) 
TALC(7SEV7J4R1U)                             
TRIETHYL CITRATE(8Z96QXD6UM)