NDC 49708-146

Bactrim DS

Sulfamethoxazole And Trimethoprim

Bactrim DS is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc. The primary component is Sulfamethoxazole; Trimethoprim.

Product ID	49708-146_33fdfd3a-de42-4afc-8ea3-d95f1773166e
NDC	49708-146
Product Type	Human Prescription Drug
Proprietary Name	Bactrim DS
Generic Name	Sulfamethoxazole And Trimethoprim
Dosage Form	Tablet
Route of Administration	ORAL
Marketing Start Date	2004-11-01
Marketing Category	NDA / NDA
Application Number	NDA017377
Labeler Name	Sun Pharmaceutical Industries, Inc
Substance Name	SULFAMETHOXAZOLE; TRIMETHOPRIM
Active Ingredient Strength	800 mg/1; mg/1
Pharm Classes	Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC Exclude Flag	N
Listing Certified Through	2021-12-31

Packaging

NDC 49708-146-01

100 TABLET in 1 BOTTLE, PLASTIC (49708-146-01)

Marketing Start Date	2004-11-01
NDC Exclude Flag	N
Sample Package?	N

NDC SPL Data Element Entries

NDC 49708-146-01 [49708014601]

Bactrim DS TABLET

Marketing Category	NDA
Application Number	NDA017377
Product Type	HUMAN PRESCRIPTION DRUG
Billing Unit	EA
Marketing Start Date	2004-11-01

Drug Details

Active Ingredients

Ingredient	Strength
SULFAMETHOXAZOLE	800 mg/1

OpenFDA Data

SPL SET ID:	f59d0c04-9c66-4d53-a0e1-cb55570deb62
Manufacturer	Sun Pharmaceutical Industries, Inc
UNII	AN164J8Y0X JE42381TNV
RxNorm Concept Unique ID - RxCUI	198334 198335 849580 208416

Pharmacological Class

Dihydrofolate Reductase Inhibitor Antibacterial [EPC]
Dihydrofolate Reductase Inhibitors [MoA]
Cytochrome P450 2C8 Inhibitors [MoA]
Organic Cation Transporter 2 Inhibitors [MoA]
Sulfonamide Antimicrobial [EPC]
Sulfonamides [CS]
Cytochrome P450 2C9 Inhibitors [MoA]
Dihydrofolate Reductase Inhibitor Antibacterial [EPC]
Dihydrofolate Reductase Inhibitors [MoA]
Cytochrome P450 2C8 Inhibitors [MoA]
Organic Cation Transporter 2 Inhibitors [MoA]
Sulfonamide Antimicrobial [EPC]
Sulfonamides [CS]
Cytochrome P450 2C9 Inhibitors [MoA]

NDC Crossover Matching brand name "Bactrim DS" or generic name "Sulfamethoxazole And Trimethoprim"