Label: PRED-GATI- prednisolone-gatifloxacin suspension
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Contains inactivated NDC Code(s)
NDC Code(s): 70261-502-03 - Packager: ImprimisRx NJ
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated February 22, 2018
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INGREDIENTS AND APPEARANCE
PRED-GATI
prednisolone-gatifloxacin suspensionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70261-502 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PREDNISOLONE ACETATE (UNII: 8B2807733D) (PREDNISOLONE - UNII:9PHQ9Y1OLM) PREDNISOLONE ACETATE 10 mg in 1 mL GATIFLOXACIN HEMIHYDRATE (UNII: AN201CY09J) (GATIFLOXACIN - UNII:L4618BD7KJ) GATIFLOXACIN HEMIHYDRATE 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) 1.9 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70261-502-03 3.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 03/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/01/2018 Labeler - ImprimisRx NJ (931390178)
