polymyxin b sulfate and trimethoprim

Generic: polymyxin b sulfate and trimethoprim sulfate

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name polymyxin b sulfate and trimethoprim
Generic Name polymyxin b sulfate and trimethoprim sulfate
Labeler proficient rx lp
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

polymyxin b sulfate 10000 [USP'U]/mL, trimethoprim sulfate 1 mg/mL

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-631
Product ID 63187-631_38978a23-dfcb-4930-96a7-15f42fe54e56
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064120
Listing Expiration 2026-12-31
Marketing Start 1997-02-14

Pharmacologic Class

Classes
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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187631
Hyphenated Format 63187-631

Supplemental Identifiers

RxCUI
244967
UPC
0363187631109
UNII
19371312D4 E377MF8EQ8

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 (source: ndc)
Generic Name polymyxin b sulfate and trimethoprim sulfate (source: ndc)
Application Number ANDA064120 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10000 [USP'U]/mL
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (63187-631-10) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

63187-631-10 1 BOTTLE, DROPPER in 1 CARTON (63187-631-10) / 10 mL in 1 BOTTLE, DROPPER

Ingredients (2)

polymyxin b sulfate (10000 [USP'U]/mL) trimethoprim sulfate (1 mg/mL)

Linked Drug Pages (1)

Polymyxin B Sulfate and Trimethoprim ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "38978a23-dfcb-4930-96a7-15f42fe54e56", "openfda": {"upc": ["0363187631109"], "unii": ["19371312D4", "E377MF8EQ8"], "rxcui": ["244967"], "spl_set_id": ["d1f55327-156f-44cd-b0fc-b1a938e8aa73"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (63187-631-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "63187-631-10", "marketing_start_date": "20181201"}], "brand_name": "Polymyxin B Sulfate and Trimethoprim", "product_id": "63187-631_38978a23-dfcb-4930-96a7-15f42fe54e56", "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": "63187-631", "generic_name": "Polymyxin B Sulfate and Trimethoprim Sulfate", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Polymyxin B Sulfate and Trimethoprim", "active_ingredients": [{"name": "POLYMYXIN B SULFATE", "strength": "10000 [USP'U]/mL"}, {"name": "TRIMETHOPRIM SULFATE", "strength": "1 mg/mL"}], "application_number": "ANDA064120", "marketing_category": "ANDA", "marketing_start_date": "19970214", "listing_expiration_date": "20261231"}