NDC 62332-508

Bromfenac Ophthalmic Solution 0.09%

Bromfenac Ophthalmic Solution 0.09%

Bromfenac Ophthalmic Solution 0.09% is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Inc.. The primary component is Bromfenac Sodium.

• Product ID: 62332-508_0f23c0b7-02d5-43b8-a39e-893c0883f77b
• NDC: 62332-508
• Product Type: Human Prescription Drug
• Proprietary Name: Bromfenac Ophthalmic Solution 0.09%
• Generic Name: Bromfenac Ophthalmic Solution 0.09%
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2019-06-21
• Marketing Category: ANDA / ANDA
• Application Number: ANDA210560
• Labeler Name: Alembic Pharmaceuticals 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: 2022-12-31

Packaging

NDC 62332-508-17

1 BOTTLE in 1 CARTON (62332-508-17) > 1.7 mL in 1 BOTTLE

• Marketing Start Date: 2019-06-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 62332-508-17 [62332050817]

Bromfenac Ophthalmic Solution 0.09% SOLUTION/ DROPS

• Marketing Category: ANDA
• Application Number: ANDA210560
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-06-21

Drug Details

Active Ingredients

Ingredient	Strength
BROMFENAC SODIUM	1.035 mg/mL

OpenFDA Data

• SPL SET ID: 225070ee-d862-4d41-84b8-5bd7a8a03fd7
• Manufacturer:
  • Alembic Pharmaceuticals Inc.
• UNII:
  • 8ECV571Y37
• RxNorm Concept Unique ID - RxCUI:
  • 578018
• UPC Code:
  • 0362332508174

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]