NDC 68788-0536

Trimethoprim sulfate and Polymyxin B sulfate

Trimethoprim Sulfate And Polymyxin B Sulfate

Trimethoprim sulfate and Polymyxin B sulfate is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals Inc.. The primary component is Trimethoprim Sulfate; Polymyxin B Sulfate.

• Product ID: 68788-0536_446a5a74-06a4-43c1-a42b-2a0ffcb12185
• NDC: 68788-0536
• Product Type: Human Prescription Drug
• Proprietary Name: Trimethoprim sulfate and Polymyxin B sulfate
• Generic Name: Trimethoprim Sulfate And Polymyxin B Sulfate
• Dosage Form: Solution
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2015-10-20
• Marketing Category: ANDA / ANDA
• Application Number: ANDA065006
• Labeler Name: Preferred Pharmaceuticals Inc.
• Substance Name: TRIMETHOPRIM SULFATE; POLYMYXIN B SULFATE
• Active Ingredient Strength: 1 mg/mL; [USP'U]/mL
• Pharm Classes: Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 68788-0536-1

10 mL in 1 BOTTLE, DROPPER (68788-0536-1)

• Marketing Start Date: 2015-10-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68788-0536-1 [68788053601]

Trimethoprim sulfate and Polymyxin B sulfate SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA065006
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-10-20

Drug Details

Active Ingredients

Ingredient	Strength
TRIMETHOPRIM SULFATE	1 mg/mL

OpenFDA Data

• SPL SET ID: cd62953d-3cdb-46b9-9996-6435fde9831f
• Manufacturer:
  • Preferred Pharmaceuticals Inc.
• UNII:
  • 19371312D4
  • E377MF8EQ8
• RxNorm Concept Unique ID - RxCUI:
  • 244967

Pharmacological Class

• Dihydrofolate Reductase Inhibitor Antibacterial [EPC]
• Dihydrofolate Reductase Inhibitors [MoA]
• Cytochrome P450 2C8 Inhibitors [MoA]
• Organic Cation Transporter 2 Inhibitors [MoA]
• Polymyxin-class Antibacterial [EPC]
• Polymyxins [CS]

NDC Crossover Matching brand name "Trimethoprim sulfate and Polymyxin B sulfate" or generic name "Trimethoprim Sulfate And Polymyxin B Sulfate"

NDC	Brand Name	Generic Name
17478-703	Trimethoprim sulfate and Polymyxin B sulfate	Trimethoprim sulfate and Polymyxin B sulfate
55700-414	Trimethoprim sulfate and Polymyxin B sulfate	Trimethoprim sulfate and Polymyxin B sulfate
63187-193	Trimethoprim sulfate and Polymyxin B sulfate	Trimethoprim sulfate and Polymyxin B sulfate
68788-0536	Trimethoprim sulfate and Polymyxin B sulfate	Trimethoprim sulfate and Polymyxin B sulfate
70518-1194	Trimethoprim sulfate and Polymyxin B sulfate	Trimethoprim sulfate and Polymyxin B sulfate