Polymyxin B Sulfate and Trimethoprim

Product NDC
70518-0271
11-digit product format
705180271
Labeler code
70518
Product ID
70518-0271_835e03e0-5091-ecce-e053-2991aa0a757a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Polymyxin B Sulfate and Trimethoprim Sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
REMEDYREPACK INC.
Application
ANDA064120
Marketing category
ANDA
Marketing start
2017-03-02
Marketing end
0000-00-00
Substance
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
Active strength
10000 [USP'U]/mL; mg/mL
Pharmacologic classes
Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0271POLYMYXIN B SULFATE AND TRIMETHOPRIM (POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [REMEDYREPACK INC.]8Legacy NDC20250425_4c7f80fc-257c-498b-bf6e-cfa982f9a3bc.zip