NDC 61919-989

AK-POLY-BAC

Ak-poly-bac

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

• Product ID: 61919-989_40f31994-e46a-0d3f-e054-00144ff88e88
• NDC: 61919-989
• Product Type: Human Prescription Drug
• Proprietary Name: AK-POLY-BAC
• Generic Name: Ak-poly-bac
• Dosage Form: Ointment
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2014-01-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA064028
• Labeler Name: DIRECT RX
• Substance Name: BACITRACIN ZINC; POLYMYXIN B SULFATE
• Active Ingredient Strength: 500 [USP'U]/g; [USP'U]/g
• Pharm Classes: Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 61919-989-35

3.5 g in 1 CARTON (61919-989-35)

• Marketing Start Date: 2015-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61919-989-35 [61919098935]

AK-POLY-BAC OINTMENT

• Marketing Category: ANDA
• Application Number: ANDA064028
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2015-01-01

Drug Details

Active Ingredients

Ingredient	Strength
BACITRACIN ZINC	500 [USP'U]/g

OpenFDA Data

• SPL SET ID: 1df13524-99f3-416c-94f8-4f6e16eb1c7e
• Manufacturer:
  • DIRECT RX
• UNII:
  • 89Y4M234ES
  • 19371312D4
• RxNorm Concept Unique ID - RxCUI:
  • 308511

Pharmacological Class

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

NDC Crossover Matching brand name "AK-POLY-BAC" or generic name "Ak-poly-bac"

NDC	Brand Name	Generic Name
17478-238	AK-POLY-BAC	Bacitracin Zinc and Polymyxin B Sulfate
50090-0447	AK-POLY-BAC	Bacitracin Zinc and Polymyxin B Sulfate
61919-989	AK-POLY-BAC	AK-POLY-BAC