polymyxin b sulfate and trimethoprim sulfate

Generic: polymyxin b sulfate and trimethoprim sulfate

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name polymyxin b sulfate and trimethoprim sulfate
Generic Name polymyxin b sulfate and trimethoprim sulfate
Labeler somerset therapeutics, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

polymyxin b sulfate 10000 [iU]/mL, trimethoprim 1 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-311
Product ID 70069-311_80ad4adc-72c3-4398-a639-3d6a6ae9ec17
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211572
Listing Expiration 2026-12-31
Marketing Start 2024-08-06

Pharmacologic Class

Established (EPC)
dihydrofolate reductase inhibitor antibacterial [epc]
Mechanism of Action
dihydrofolate reductase inhibitors [moa] cytochrome p450 2c8 inhibitors [moa] organic cation transporter 2 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069311
Hyphenated Format 70069-311

Supplemental Identifiers

RxCUI
244967
UPC
0370069311011
UNII
19371312D4 AN164J8Y0X
NUI
N0000175489 N0000000191 N0000187062 N0000187061

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 polymyxin b sulfate and trimethoprim sulfate (source: ndc)
Generic Name polymyxin b sulfate and trimethoprim sulfate (source: ndc)
Application Number ANDA211572 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10000 [iU]/mL
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70069-311-01) / 10 mL in 1 BOTTLE
source: ndc

Packages (1)

70069-311-01 1 BOTTLE in 1 CARTON (70069-311-01) / 10 mL in 1 BOTTLE

Ingredients (2)

polymyxin b sulfate (10000 [iU]/mL) trimethoprim (1 mg/mL)

Linked Drug Pages (1)

polymyxin b sulfate and trimethoprim sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "80ad4adc-72c3-4398-a639-3d6a6ae9ec17", "openfda": {"nui": ["N0000175489", "N0000000191", "N0000187062", "N0000187061"], "upc": ["0370069311011"], "unii": ["19371312D4", "AN164J8Y0X"], "rxcui": ["244967"], "spl_set_id": ["93d52a75-9a96-4f96-be41-9ccdcabc0933"], "pharm_class_epc": ["Dihydrofolate Reductase Inhibitor Antibacterial [EPC]"], "pharm_class_moa": ["Dihydrofolate Reductase Inhibitors [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70069-311-01)  / 10 mL in 1 BOTTLE", "package_ndc": "70069-311-01", "marketing_start_date": "20240806"}], "brand_name": "polymyxin b sulfate and trimethoprim sulfate", "product_id": "70069-311_80ad4adc-72c3-4398-a639-3d6a6ae9ec17", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Cytochrome P450 2C8 Inhibitors [MoA]", "Dihydrofolate Reductase Inhibitor Antibacterial [EPC]", "Dihydrofolate Reductase Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "70069-311", "generic_name": "polymyxin b sulfate and trimethoprim sulfate", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "polymyxin b sulfate and trimethoprim sulfate", "active_ingredients": [{"name": "POLYMYXIN B SULFATE", "strength": "10000 [iU]/mL"}, {"name": "TRIMETHOPRIM", "strength": "1 mg/mL"}], "application_number": "ANDA211572", "marketing_category": "ANDA", "marketing_start_date": "20240806", "listing_expiration_date": "20261231"}