sulfamethoxazole and trimethoprim

Generic: sulfamethoxazole and trimethoprim

Labeler: atlantic biologicals corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sulfamethoxazole and trimethoprim
Generic Name sulfamethoxazole and trimethoprim
Labeler atlantic biologicals corp.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

sulfamethoxazole 200 mg/5mL, trimethoprim 40 mg/5mL

Manufacturer
ATLANTIC BIOLOGICALS CORP.

Identifiers & Regulatory

Product NDC 17856-0496
Product ID 17856-0496_361f7b6e-a67d-c21a-e063-6394a90ad8ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091348
Listing Expiration 2026-12-31
Marketing Start 2017-10-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 178560496
Hyphenated Format 17856-0496

Supplemental Identifiers

RxCUI
313134
UNII
JE42381TNV AN164J8Y0X
NUI
N0000175504 M0020790 N0000185504 N0000175489 N0000000191 N0000187062 N0000187061

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 ANDA091348 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/5mL
  • 40 mg/5mL
source: ndc
Packaging
  • 72 CUP, UNIT-DOSE in 1 BOX (17856-0496-4) / 5 mL in 1 CUP, UNIT-DOSE (17856-0496-1)
  • 50 CUP, UNIT-DOSE in 1 BOX (17856-0496-5) / 20 mL in 1 CUP, UNIT-DOSE (17856-0496-3)
  • 72 CUP, UNIT-DOSE in 1 BOX (17856-0496-6) / 10 mL in 1 CUP, UNIT-DOSE (17856-0496-2)
source: ndc

Packages (3)

17856-0496-4 72 CUP, UNIT-DOSE in 1 BOX (17856-0496-4) / 5 mL in 1 CUP, UNIT-DOSE (17856-0496-1) 17856-0496-5 50 CUP, UNIT-DOSE in 1 BOX (17856-0496-5) / 20 mL in 1 CUP, UNIT-DOSE (17856-0496-3) 17856-0496-6 72 CUP, UNIT-DOSE in 1 BOX (17856-0496-6) / 10 mL in 1 CUP, UNIT-DOSE (17856-0496-2)

Ingredients (2)

sulfamethoxazole (200 mg/5mL) trimethoprim (40 mg/5mL)

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": "361f7b6e-a67d-c21a-e063-6394a90ad8ba", "openfda": {"nui": ["N0000175504", "M0020790", "N0000185504", "N0000175489", "N0000000191", "N0000187062", "N0000187061"], "unii": ["JE42381TNV", "AN164J8Y0X"], "rxcui": ["313134"], "spl_set_id": ["acc3df02-1e99-46e6-8a31-9b26261c6daa"], "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": ["ATLANTIC BIOLOGICALS CORP."]}, "finished": true, "packaging": [{"sample": false, "description": "72 CUP, UNIT-DOSE in 1 BOX (17856-0496-4)  / 5 mL in 1 CUP, UNIT-DOSE (17856-0496-1)", "package_ndc": "17856-0496-4", "marketing_start_date": "20240412"}, {"sample": false, "description": "50 CUP, UNIT-DOSE in 1 BOX (17856-0496-5)  / 20 mL in 1 CUP, UNIT-DOSE (17856-0496-3)", "package_ndc": "17856-0496-5", "marketing_start_date": "20240412"}, {"sample": false, "description": "72 CUP, UNIT-DOSE in 1 BOX (17856-0496-6)  / 10 mL in 1 CUP, UNIT-DOSE (17856-0496-2)", "package_ndc": "17856-0496-6", "marketing_start_date": "20240412"}], "brand_name": "Sulfamethoxazole and Trimethoprim", "product_id": "17856-0496_361f7b6e-a67d-c21a-e063-6394a90ad8ba", "dosage_form": "SUSPENSION", "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": "17856-0496", "generic_name": "Sulfamethoxazole and Trimethoprim", "labeler_name": "ATLANTIC BIOLOGICALS CORP.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sulfamethoxazole and Trimethoprim", "active_ingredients": [{"name": "SULFAMETHOXAZOLE", "strength": "200 mg/5mL"}, {"name": "TRIMETHOPRIM", "strength": "40 mg/5mL"}], "application_number": "ANDA091348", "marketing_category": "ANDA", "marketing_start_date": "20171004", "listing_expiration_date": "20261231"}