bactrim

Generic: sulfamethoxazole and trimethoprim

Labeler: sun pharmaceutical industries, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name bactrim
Generic Name sulfamethoxazole and trimethoprim
Labeler sun pharmaceutical industries, inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sulfamethoxazole 400 mg/1, trimethoprim 80 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc

Identifiers & Regulatory

Product NDC 49708-145
Product ID 49708-145_2a76a544-1f84-4b42-e063-6394a90a08d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017377
Listing Expiration 2026-12-31
Marketing Start 2004-11-01

Pharmacologic Class

Established (EPC)
dihydrofolate reductase inhibitor antibacterial [epc] sulfonamide antimicrobial [epc]
Mechanism of Action
dihydrofolate reductase inhibitors [moa] cytochrome p450 2c8 inhibitors [moa] organic cation transporter 2 inhibitors [moa] cytochrome p450 2c9 inhibitors [moa]
Chemical Structure
sulfonamides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49708145
Hyphenated Format 49708-145

Supplemental Identifiers

RxCUI
198334 198335 208416 849580
UPC
0349708146017 0349708145010
UNII
AN164J8Y0X JE42381TNV
NUI
N0000175489 N0000000191 N0000187062 N0000187061 N0000175504 M0020790 N0000185504

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bactrim (source: ndc)
Generic Name sulfamethoxazole and trimethoprim (source: ndc)
Application Number NDA017377 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
  • 80 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (49708-145-01)
source: ndc

Packages (1)

49708-145-01 100 TABLET in 1 BOTTLE, PLASTIC (49708-145-01)

Ingredients (2)

sulfamethoxazole (400 mg/1) trimethoprim (80 mg/1)

Linked Drug Pages (1)

Bactrim, Bactrim DS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a76a544-1f84-4b42-e063-6394a90a08d5", "openfda": {"nui": ["N0000175489", "N0000000191", "N0000187062", "N0000187061", "N0000175504", "M0020790", "N0000185504"], "upc": ["0349708146017", "0349708145010"], "unii": ["AN164J8Y0X", "JE42381TNV"], "rxcui": ["198334", "198335", "208416", "849580"], "spl_set_id": ["f59d0c04-9c66-4d53-a0e1-cb55570deb62"], "pharm_class_cs": ["Sulfonamides [CS]"], "pharm_class_epc": ["Dihydrofolate Reductase Inhibitor Antibacterial [EPC]", "Sulfonamide Antimicrobial [EPC]"], "pharm_class_moa": ["Dihydrofolate Reductase Inhibitors [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (49708-145-01)", "package_ndc": "49708-145-01", "marketing_start_date": "20041101"}], "brand_name": "Bactrim", "product_id": "49708-145_2a76a544-1f84-4b42-e063-6394a90a08d5", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Dihydrofolate Reductase Inhibitor Antibacterial [EPC]", "Dihydrofolate Reductase Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]", "Sulfonamide Antimicrobial [EPC]", "Sulfonamides [CS]"], "product_ndc": "49708-145", "generic_name": "sulfamethoxazole and Trimethoprim", "labeler_name": "Sun Pharmaceutical Industries, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bactrim", "active_ingredients": [{"name": "SULFAMETHOXAZOLE", "strength": "400 mg/1"}, {"name": "TRIMETHOPRIM", "strength": "80 mg/1"}], "application_number": "NDA017377", "marketing_category": "NDA", "marketing_start_date": "20041101", "listing_expiration_date": "20261231"}