NDC 70261-504

Pred-Gati-Brom

Prednisolone-gatifloxacin-bromfenac

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

• Product ID: 70261-504_65d1a00a-54fc-5afd-e053-2991aa0a69a9
• NDC: 70261-504
• Product Type: Human Prescription Drug
• Proprietary Name: Pred-Gati-Brom
• Generic Name: Prednisolone-gatifloxacin-bromfenac
• Dosage Form: Suspension/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2018-01-01
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: ImprimisRx NJ
• Substance Name: GATIFLOXACIN HEMIHYDRATE; BROMFENAC; PREDNISOLONE ACETATE
• Active Ingredient Strength: 5 mg/mL; mg/mL; mg/mL
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 70261-504-03

3.5 mL in 1 BOTTLE, DROPPER (70261-504-03)

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

NDC SPL Data Element Entries

NDC 70261-504-03 [70261050403]

Pred-Gati-Brom SUSPENSION/ DROPS

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-01-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
GATIFLOXACIN HEMIHYDRATE	5 mg/mL

OpenFDA Data

• SPL SET ID: 65d1a00a-54fb-5afd-e053-2991aa0a69a9
• Manufacturer:
  • ImprimisRx NJ
• UNII:
  • 864P0921DW
  • 8B2807733D
  • AN201CY09J
• 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]
• 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-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