NDC 71384-551

Pred Phos - Gati

Prednisolone Phosphate - Gatifloxacin

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

• Product ID: 71384-551_6e284a6a-7c82-bf88-e053-2991aa0a28a5
• NDC: 71384-551
• Product Type: Human Prescription Drug
• Proprietary Name: Pred Phos - Gati
• Generic Name: Prednisolone Phosphate - Gatifloxacin
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2018-07-02
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Imprimis NJOF, LLC
• Substance Name: PREDNISOLONE SODIUM PHOSPHATE; GATIFLOXACIN
• Active Ingredient Strength: 10 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 71384-551-03

3.5 mL in 1 BOTTLE, DROPPER (71384-551-03)

• Marketing Start Date: 2018-07-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71384-551-03 [71384055103]

Pred Phos - Gati SOLUTION/ DROPS

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

Drug Details

Active Ingredients

Ingredient	Strength
PREDNISOLONE SODIUM PHOSPHATE	10 mg/mL

OpenFDA Data

• SPL SET ID: 6e284a6a-7c81-bf88-e053-2991aa0a28a5
• Manufacturer:
  • Imprimis NJOF, LLC
• UNII:
  • IV021NXA9J
  • L4618BD7KJ

Pharmacological Class

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