Sulfamethoxazole and Trimethoprim

Basic Information

Product Name

FDA Product Code

21695-701

Regulatory Information

NDC Product Code

21695-701

Application Number

ANDA074650

Marketing Category

C73584

Effective Date

October 21, 2009

Territorial Authority

USA

FDA Title

Sulfamethoxazole and Trimethoprim Oral Suspension, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SULFAMETHOXAZOLE

Quantity: 200 mg in 5 mL

Code: JE42381TNV

Class Code: ACTIB

TRIMETHOPRIM

Quantity: 40 mg in 5 mL

Code: AN164J8Y0X

Class Code: ACTIB

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

SODIUM BENZOATE

Code: OJ245FE5EU

Class Code: IACT

SACCHARIN SODIUM

Code: SB8ZUX40TY

Class Code: IACT

CARBOXYMETHYLCELLULOSE SODIUM

Code: K679OBS311

Class Code: IACT

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

SORBITOL

Code: 506T60A25R

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

CHERRY

Code: BUC5I9595W

Class Code: IACT

Active Moieties