NDC 49708-754

BromSite 0.075%

Bromfenac

BromSite 0.075% is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Bromfenac Sodium.

• Product ID: 49708-754_3ae02266-5a0f-4bf2-bc68-ae1c7d2f5239
• NDC: 49708-754
• Product Type: Human Prescription Drug
• Proprietary Name: BromSite 0.075%
• Generic Name: Bromfenac
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2016-05-01
• Marketing Category: NDA / NDA
• Application Number: NDA206911
• Labeler Name: Sun Pharmaceutical Industries, Inc.
• 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: 2020-12-31

Packaging

NDC 49708-754-41

1 POUCH in 1 CARTON (49708-754-41) > 1 BOTTLE, DROPPER in 1 POUCH > 5 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2016-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49708-754-41 [49708075441]

BromSite 0.075% SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA206911
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-05-01

Drug Details

Active Ingredients

Ingredient	Strength
BROMFENAC SODIUM	.76 mg/mL

OpenFDA Data

• SPL SET ID: 144a5072-341b-4591-8705-773b63044bcc
• Manufacturer:
  • Sun Pharmaceutical Industries, Inc.
• UNII:
  • 8ECV571Y37
• RxNorm Concept Unique ID - RxCUI:
  • 1790146
  • 1790141
• UPC Code:
  • 0331357040259

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

49708075441 BROMSITE 0.075% EYE DROPS

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "BromSite 0.075%" or generic name "Bromfenac"

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