NDC 61919-111

POLYCIN

Bacitracin Zinc And Polymyxin B Sulfates

POLYCIN is a Ophthalmic Ointment in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Polymyxin B Sulfate; Bacitracin Zinc.

• Product ID: 61919-111_4be2ae47-ce1f-6212-e054-00144ff88e88
• NDC: 61919-111
• Product Type: Human Prescription Drug
• Proprietary Name: POLYCIN
• Generic Name: Bacitracin Zinc And Polymyxin B Sulfates
• Dosage Form: Ointment
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2017-03-29
• Marketing Category: ANDA / ANDA
• Application Number: ANDA065022
• Labeler Name: DIRECT RX
• Substance Name: POLYMYXIN B SULFATE; BACITRACIN ZINC
• Active Ingredient Strength: 10000 [USP'U]/g; [USP'U]/g
• Pharm Classes: Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Decreased Cell Wall Synthesis & Repair [PE]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 61919-111-35

1 g in 1 CARTON (61919-111-35)

• Marketing Start Date: 2017-03-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61919-111-35 [61919011135]

POLYCIN OINTMENT

• Marketing Category: ANDA
• Application Number: ANDA065022
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2017-03-29

Drug Details

Active Ingredients

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

OpenFDA Data

• SPL SET ID: 4be2ae47-ce1e-6212-e054-00144ff88e88
• Manufacturer:
  • DIRECT RX
• UNII:
  • 89Y4M234ES
  • 19371312D4
• RxNorm Concept Unique ID - RxCUI:
  • 308511
  • 213621

Pharmacological Class

• Polymyxin-class Antibacterial [EPC]
• Polymyxins [CS]
• Decreased Cell Wall Synthesis & Repair [PE]

NDC Crossover Matching brand name "POLYCIN" or generic name "Bacitracin Zinc And Polymyxin B Sulfates"

NDC	Brand Name	Generic Name
0574-4021	polycin	bacitracin zinc and polymyxin b sulfates
50090-1653	polycin	bacitracin zinc and polymyxin b sulfates
53002-9270	polycin	bacitracin zinc and polymyxin b sulfates
61919-111	POLYCIN	bacitracin zinc and polymyxin b sulfates
66267-925	polycin	bacitracin zinc and polymyxin b sulfates