NDC 70261-502

Pred-Gati

Prednisolone-gatifloxacin

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

• Product ID: 70261-502_65d1ebbd-b3d4-59ca-e053-2991aa0a1874
• NDC: 70261-502
• Product Type: Human Prescription Drug
• Proprietary Name: Pred-Gati
• Generic Name: Prednisolone-gatifloxacin
• Dosage Form: Suspension
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2018-03-01
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: ImprimisRx NJ
• Substance Name: PREDNISOLONE ACETATE; GATIFLOXACIN HEMIHYDRATE
• Active Ingredient Strength: 10 mg/mL; mg/mL
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 70261-502-03

3.5 mL in 1 BOTTLE, DROPPER (70261-502-03)

• Marketing Start Date: 2018-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70261-502-03 [70261050203]

Pred-Gati SUSPENSION

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-03-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
PREDNISOLONE ACETATE	10 mg/mL

OpenFDA Data

• SPL SET ID: 65346afa-45cf-9f3b-e053-2991aa0ac8b1
• Manufacturer:
  • ImprimisRx NJ
• UNII:
  • 8B2807733D
  • AN201CY09J

Pharmacological Class

• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]

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

NDC	Brand Name	Generic Name
70261-502	Pred-Gati	Prednisolone-Gatifloxacin
71384-502	Pred-Gati	Prednisolone Acetate-Gatifloxacin