NDC 61919-215

POLYMYXIN B SULFATE AND TRIMETHOPRIM

Polymyxin B Sulfate And Trimethoprim

POLYMYXIN B SULFATE AND TRIMETHOPRIM is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Trimethoprim Sulfate; Polymyxin B Sulfate.

• Product ID: 61919-215_50bdf240-8b96-6032-e054-00144ff88e88
• NDC: 61919-215
• Product Type: Human Prescription Drug
• Proprietary Name: POLYMYXIN B SULFATE AND TRIMETHOPRIM
• Generic Name: Polymyxin B Sulfate And Trimethoprim
• Dosage Form: Solution
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2017-05-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA064211
• Labeler Name: DIRECT RX
• 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: 2020-12-31

Packaging

NDC 61919-215-10

10 mL in 1 BOTTLE, PLASTIC (61919-215-10)

• Marketing Start Date: 2017-05-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61919-215-10 [61919021510]

POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA064211
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-05-30

Drug Details

Active Ingredients

Ingredient	Strength
TRIMETHOPRIM SULFATE	1 mg/mL

OpenFDA Data

• SPL SET ID: 50bdf240-8b95-6032-e054-00144ff88e88
• Manufacturer:
  • DIRECT RX
• 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]
• 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 "POLYMYXIN B SULFATE AND TRIMETHOPRIM" or generic name "Polymyxin B Sulfate And Trimethoprim"

NDC	Brand Name	Generic Name
17478-703	POLYMYXIN B SULFATE AND TRIMETHOPRIM	polymyxin b sulfate and trimethoprim
21695-335	Polymyxin B Sulfate and Trimethoprim	polymyxin B sulfate and trimethoprim
24208-315	Polymyxin B Sulfate and Trimethoprim	Polymyxin B Sulfate and Trimethoprim Sulfate
50090-2398	Polymyxin B Sulfate and Trimethoprim	Polymyxin B Sulfate and Trimethoprim Sulfate
50090-2925	Polymyxin B Sulfate and Trimethoprim	Polymyxin B Sulfate and Trimethoprim
50436-4335	Polymyxin B Sulfate and Trimethoprim	Polymyxin B Sulfate and Trimethoprim Sulfate
53002-8620	Polymyxin B Sulfate and Trimethoprim	Polymyxin B Sulfate and Trimethoprim Sulfate
53002-8621	Polymyxin B Sulfate and Trimethoprim	Polymyxin B Sulfate and Trimethoprim
53217-244	Polymyxin B Sulfate and Trimethoprim	Polymyxin B Sulfate and Trimethoprim Sulfate
53217-305	Polymyxin B Sulfate and Trimethoprim	Polymyxin B Sulfate and Trimethoprim
61314-628	Polymyxin B Sulfate and Trimethoprim	Polymyxin B Sulfate and Trimethoprim
61919-115	POLYMYXIN B SULFATE AND TRIMETHOPRIM	POLYMYXIN B SULFATE AND TRIMETHOPRIM
61919-215	POLYMYXIN B SULFATE AND TRIMETHOPRIM	POLYMYXIN B SULFATE AND TRIMETHOPRIM
63187-631	Polymyxin B Sulfate and Trimethoprim	Polymyxin B Sulfate and Trimethoprim Sulfate
63187-834	Polymyxin B Sulfate and Trimethoprim	Polymyxin B Sulfate and Trimethoprim
68071-1651	Polymyxin B Sulfate and Trimethoprim	Polymyxin B Sulfate and Trimethoprim Sulfate
68071-4103	Polymyxin B Sulfate and Trimethoprim	Polymyxin B Sulfate and Trimethoprim
68788-6927	Polymyxin B Sulfate and Trimethoprim	Polymyxin B Sulfate and Trimethoprim
68788-8152	Polymyxin B Sulfate and Trimethoprim	Polymyxin B Sulfate and Trimethoprim Sulfate
70518-0271	Polymyxin B Sulfate and Trimethoprim	Polymyxin B Sulfate and Trimethoprim Sulfate
70518-1735	Polymyxin B Sulfate and Trimethoprim	Polymyxin B Sulfate and Trimethoprim
72189-005	POLYMYXIN B SULFATE AND TRIMETHOPRIM	POLYMYXIN B SULFATE AND TRIMETHOPRIM