NDC 70518-1194

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 Remedyrepack Inc.. The primary component is Trimethoprim Sulfate; Polymyxin B Sulfate.

• Product ID: 70518-1194_6cbf87bd-b618-76be-e053-2991aa0a7344
• NDC: 70518-1194
• 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: 2018-05-14
• Marketing Category: ANDA / ANDA
• Application Number: ANDA065006
• Labeler Name: REMEDYREPACK 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: 2019-12-31

Packaging

NDC 70518-1194-0

1 BOTTLE, DROPPER in 1 CARTON (70518-1194-0) > 10 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2018-05-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-1194-0 [70518119400]

Trimethoprim sulfate and Polymyxin B sulfate SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA065006
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-05-14
• Marketing End Date: 2020-05-19

Drug Details

Active Ingredients

Ingredient	Strength
TRIMETHOPRIM SULFATE	1 mg/mL

OpenFDA Data

• SPL SET ID: bdcccb04-d570-4e91-81a5-46858a122e79
• Manufacturer:
  • REMEDYREPACK 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