NDC 71384-504

Pred-Gati-Brom

Prednisolone Acetate-gatifloxacin-bromfenac

Pred-Gati-Brom is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Imprims Njof, Llc. The primary component is Bromfenac; Gatifloxacin; Prednisolone Acetate.

• Product ID: 71384-504_638a1f49-53eb-7a69-e053-2991aa0a82bc
• NDC: 71384-504
• Product Type: Human Prescription Drug
• Proprietary Name: Pred-Gati-Brom
• Generic Name: Prednisolone Acetate-gatifloxacin-bromfenac
• Dosage Form: Suspension/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2018-01-05
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Imprims NJOF, LLC
• Substance Name: BROMFENAC; GATIFLOXACIN; PREDNISOLONE ACETATE
• Active Ingredient Strength: 1 mg/mL; mg/mL; mg/mL
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Quinolone Antimicrobial [EPC],Quinolones [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 71384-504-03

20 BOTTLE, DROPPER in 1 BOX (71384-504-03) > 3.5 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2018-01-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71384-504-03 [71384050403]

Pred-Gati-Brom SUSPENSION/ DROPS

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-01-05
• Marketing End Date: 2019-07-01
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-12

Drug Details

Active Ingredients

Ingredient	Strength
BROMFENAC	.75 mg/mL

OpenFDA Data

• SPL SET ID: 62976b18-33bc-4035-e053-2991aa0a4a03
• Manufacturer:
  • Imprims NJOF, LLC
• UNII:
  • 864P0921DW
  • 8B2807733D
  • L4618BD7KJ
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
• NUI Code:
  • N0000000160
  • N0000175722
  • N0000175721

Pharmacological Class

• Cyclooxygenase Inhibitors [MoA]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]
• Quinolone Antimicrobial [EPC]
• Quinolones [CS]
• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]

NDC Crossover Matching brand name "Pred-Gati-Brom" or generic name "Prednisolone Acetate-gatifloxacin-bromfenac"

NDC	Brand Name	Generic Name
70261-504	Pred-Gati-Brom	Prednisolone-Gatifloxacin-Bromfenac
71384-503	Pred-Gati-Brom	Prednisolone Acetate-Gatifloxacin-Bromfenac
71384-504	Pred-Gati-Brom	Prednisolone Acetate-Gatifloxacin-Bromfenac