NDC 53002-8621

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 Rpk Pharmaceuticals, Inc.. The primary component is Polymyxin B Sulfate; Trimethoprim Sulfate.

• Product ID: 53002-8621_334a7d54-bb53-465e-a119-aa88b04d40a3
• NDC: 53002-8621
• 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: 1998-04-16
• Marketing Category: ANDA / ANDA
• Application Number: ANDA064211
• Labeler Name: RPK Pharmaceuticals, Inc.
• Substance Name: POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
• Active Ingredient Strength: 10000 [USP'U]/mL; mg/mL
• Pharm 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: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 53002-8621-1

10 mL in 1 BOTTLE, DROPPER (53002-8621-1)

• Marketing Start Date: 2018-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53002-8621-1 [53002862101]

Polymyxin B Sulfate and Trimethoprim SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA064211
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-10-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
POLYMYXIN B SULFATE	10000 [USP'U]/mL

OpenFDA Data

• SPL SET ID: 76e1be2e-eb19-48d4-9bfb-88537de839ba
• Manufacturer:
  • RPK Pharmaceuticals, Inc.
• UNII:
  • E377MF8EQ8
  • 19371312D4
• RxNorm Concept Unique ID - RxCUI:
  • 244967

Pharmacological Class

• 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 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