NDC 50383-249

bromfenac

Bromfenac

bromfenac is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Akorn. The primary component is Bromfenac Sodium.

• Product ID: 50383-249_835249a6-2d83-4ecd-b2a4-4539e2f8709d
• NDC: 50383-249
• Product Type: Human Prescription Drug
• Proprietary Name: bromfenac
• Generic Name: Bromfenac
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2014-01-22
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203395
• Labeler Name: Akorn
• Substance Name: BROMFENAC SODIUM
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 50383-249-71

1 BOTTLE, DROPPER in 1 CARTON (50383-249-71) > 1.7 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2014-01-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50383-249-71 [50383024971]

bromfenac SOLUTION/ DROPS

• Marketing Category: ANDA
• Application Number: ANDA203395
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-01-22

Drug Details

Active Ingredients

Ingredient	Strength
BROMFENAC SODIUM	1.035 mg/mL

OpenFDA Data

• SPL SET ID: e853723e-8419-4444-89e9-ee3f571b0974
• Manufacturer:
  • Hi-Tech Pharmacal Co., Inc.
• UNII:
  • 8ECV571Y37
• RxNorm Concept Unique ID - RxCUI:
  • 578018

Pharmacological Class

• Cyclooxygenase Inhibitors [MoA]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]
• Cyclooxygenase Inhibitors [MoA]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]
• Nonsteroidal Anti-inflammatory Drug [EPC]

Medicade Reported Pricing

50383024971 BROMFENAC SODIUM 0.09% EYE DRP

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "bromfenac" or generic name "Bromfenac"

NDC	Brand Name	Generic Name
50383-249	bromfenac	bromfenac
65862-789	Bromfenac	Bromfenac
68083-313	BROMFENAC	Bromfenac
72266-142	BROMFENAC	Bromfenac
50436-6301	Bromday	bromfenac
49708-754	BromSite	bromfenac