NDC 68083-313

BROMFENAC

Bromfenac

BROMFENAC is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Bromfenac Sodium.

• Product ID: 68083-313_4aed36ae-5bc7-4be8-a511-a9126050e7de
• NDC: 68083-313
• Product Type: Human Prescription Drug
• Proprietary Name: BROMFENAC
• Generic Name: Bromfenac
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2020-03-17
• Marketing Category: ANDA / ANDA
• Application Number: ANDA211029
• Labeler Name: Gland Pharma Limited
• Substance Name: BROMFENAC SODIUM
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 68083-313-01

1 BOTTLE, DROPPER in 1 CARTON (68083-313-01) > 1.7 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2020-03-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68083-313-01 [68083031301]

BROMFENAC SOLUTION/ DROPS

• Marketing Category: ANDA
• Application Number: ANDA211029
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-03-17

Drug Details

Active Ingredients

Ingredient	Strength
BROMFENAC SODIUM	.9 mg/mL

OpenFDA Data

• SPL SET ID: 2120380c-81e6-43ce-9211-aad1993b9be2
• Manufacturer:
  • Gland Pharma Limited
• UNII:
  • 8ECV571Y37
• RxNorm Concept Unique ID - RxCUI:
  • 578018

Pharmacological Class

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

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