NDC 71384-506

Gati-Dex

Gatifloxacin-dexamethasone Phosphate

Gati-Dex is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Imprimis Njof, Llc. The primary component is Dexamethasone Sodium Phosphate; Gatifloxacin.

• Product ID: 71384-506_638a1f49-53e8-7a69-e053-2991aa0a82bc
• NDC: 71384-506
• Product Type: Human Prescription Drug
• Proprietary Name: Gati-Dex
• Generic Name: Gatifloxacin-dexamethasone Phosphate
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2018-01-05
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Imprimis NJOF, LLC
• Substance Name: DEXAMETHASONE SODIUM PHOSPHATE; GATIFLOXACIN
• Active Ingredient Strength: 1 mg/mL; mg/mL
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Quinolone Antimicrobial [EPC],Quinolones [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 71384-506-05

20 BOTTLE, DROPPER in 1 BOX (71384-506-05) > 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 71384-506-05 [71384050605]

Gati-Dex SOLUTION/ DROPS

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

Drug Details

Active Ingredients

Ingredient	Strength
DEXAMETHASONE SODIUM PHOSPHATE	1 mg/mL

OpenFDA Data

• SPL SET ID: 6325d560-cd47-fc9b-e053-2991aa0a719e
• Manufacturer:
  • Imprimis NJOF, LLC
• UNII:
  • AI9376Y64P
  • L4618BD7KJ

Pharmacological Class

• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]
• Quinolone Antimicrobial [EPC]
• Quinolones [CS]