polymyxin b sulfate and trimethoprim

Generic: polymyxin b sulfate and trimethoprim

Labeler: sandoz inc
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
Labeler sandoz inc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

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

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-628
Product ID 61314-628_4d36bcb4-0517-40ad-8c6e-74ca25ddae74
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064211
Listing Expiration 2026-12-31
Marketing Start 1998-04-16

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 61314628
Hyphenated Format 61314-628

Supplemental Identifiers

RxCUI
244967
UPC
0361314628107
UNII
19371312D4 E377MF8EQ8

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 (source: ndc)
Generic Name polymyxin b sulfate and trimethoprim (source: ndc)
Application Number ANDA064211 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10000 [USP'U]/mL
  • 1 mg/mL
source: ndc
Packaging
  • 10 mL in 1 BOTTLE, PLASTIC (61314-628-10)
source: ndc

Packages (1)

61314-628-10 10 mL in 1 BOTTLE, PLASTIC (61314-628-10)

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": "4d36bcb4-0517-40ad-8c6e-74ca25ddae74", "openfda": {"upc": ["0361314628107"], "unii": ["19371312D4", "E377MF8EQ8"], "rxcui": ["244967"], "spl_set_id": ["71900075-5288-4f4b-afe2-098436fa2173"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 BOTTLE, PLASTIC (61314-628-10)", "package_ndc": "61314-628-10", "marketing_start_date": "19980416"}], "brand_name": "Polymyxin B Sulfate and Trimethoprim", "product_id": "61314-628_4d36bcb4-0517-40ad-8c6e-74ca25ddae74", "dosage_form": "SOLUTION", "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": "61314-628", "generic_name": "Polymyxin B Sulfate and Trimethoprim", "labeler_name": "Sandoz Inc", "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": "ANDA064211", "marketing_category": "ANDA", "marketing_start_date": "19980416", "listing_expiration_date": "20261231"}