Sulfamethoxazole and Trimethoprim (70518-2838)

Drug Facts

Product Profile

Brand Name Sulfamethoxazole and Trimethoprim

Generic Name Sulfamethoxazole and Trimethoprim

Labeler REMEDYREPACK INC.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

SULFAMETHOXAZOLE 800 mg/1, TRIMETHOPRIM 160 mg/1

Identifiers & Regulatory

Product NDC 70518-2838

Product ID 70518-2838_39ab922c-5546-9ac3-e063-6394a90a49e6

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA076899

Listing Expiration 2026-12-31

Marketing Start 2020-08-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705182838

Hyphenated Format 70518-2838

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 Sulfamethoxazole and Trimethoprim (source: ndc)

Generic Name Sulfamethoxazole and Trimethoprim (source: ndc)

Application Number ANDA076899 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

800 mg/1
160 mg/1

source: ndc

Packaging

100 POUCH in 1 BOX (70518-2838-3) / 1 TABLET in 1 POUCH (70518-2838-4)
10 TABLET in 1 BOTTLE, PLASTIC (70518-2838-5)

source: ndc

Packages (2)

70518-2838-3 100 POUCH in 1 BOX (70518-2838-3) / 1 TABLET in 1 POUCH (70518-2838-4) 70518-2838-5 10 TABLET in 1 BOTTLE, PLASTIC (70518-2838-5)

Ingredients (2)

SULFAMETHOXAZOLE (800 mg/1) TRIMETHOPRIM (160 mg/1)

Linked Drug Pages (1)

Sulfamethoxazole and Trimethoprim ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "39ab922c-5546-9ac3-e063-6394a90a49e6", "openfda": {"nui": ["N0000175504", "M0020790", "N0000185504", "N0000175489", "N0000000191", "N0000187062", "N0000187061"], "unii": ["JE42381TNV", "AN164J8Y0X"], "rxcui": ["198335"], "spl_set_id": ["61e979f7-bfc6-4730-b21e-763e2824fde1"], "pharm_class_cs": ["Sulfonamides [CS]"], "pharm_class_epc": ["Sulfonamide Antimicrobial [EPC]", "Dihydrofolate Reductase Inhibitor Antibacterial [EPC]"], "pharm_class_moa": ["Cytochrome P450 2C9 Inhibitors [MoA]", "Dihydrofolate Reductase Inhibitors [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 POUCH in 1 BOX (70518-2838-3)  / 1 TABLET in 1 POUCH (70518-2838-4)", "package_ndc": "70518-2838-3", "marketing_start_date": "20230607"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (70518-2838-5)", "package_ndc": "70518-2838-5", "marketing_start_date": "20250313"}], "brand_name": "Sulfamethoxazole and Trimethoprim", "product_id": "70518-2838_39ab922c-5546-9ac3-e063-6394a90a49e6", "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": "70518-2838", "generic_name": "Sulfamethoxazole and Trimethoprim", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sulfamethoxazole and Trimethoprim", "active_ingredients": [{"name": "SULFAMETHOXAZOLE", "strength": "800 mg/1"}, {"name": "TRIMETHOPRIM", "strength": "160 mg/1"}], "application_number": "ANDA076899", "marketing_category": "ANDA", "marketing_start_date": "20200818", "listing_expiration_date": "20261231"}