NDC 71384-550

Pred Phos-Gati-Brom

Prednisolone Phosphate - Gatifloxacin - Bromfenac

Pred Phos-Gati-Brom 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; Bromfenac.

Product ID71384-550_6e130dfe-e946-bc9f-e053-2991aa0a55b7
NDC71384-550
Product TypeHuman Prescription Drug
Proprietary NamePred Phos-Gati-Brom
Generic NamePrednisolone Phosphate - Gatifloxacin - Bromfenac
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2018-07-02
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameImprimis NJOF, LLC
Substance NamePREDNISOLONE SODIUM PHOSPHATE; GATIFLOXACIN; BROMFENAC
Active Ingredient Strength10 mg/mL; mg/mL; mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Quinolone Antimicrobial [EPC],Quinolones [CS],Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71384-550-03

3.5 mL in 1 BOTTLE, DROPPER (71384-550-03)
Marketing Start Date2018-07-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71384-550-03 [71384055003]

Pred Phos-Gati-Brom SOLUTION/ DROPS
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-07-02
Marketing End Date2019-07-01
Inactivation Date2020-01-31
Reactivation Date2020-02-12

NDC 71384-550-07 [71384055007]

Pred Phos-Gati-Brom SOLUTION/ DROPS
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-07-02
Marketing End Date2019-07-01
Inactivation Date2020-01-31
Reactivation Date2020-02-12

Drug Details

Active Ingredients

IngredientStrength
PREDNISOLONE SODIUM PHOSPHATE10 mg/mL

OpenFDA Data

SPL SET ID:6dd75810-da95-28aa-e053-2a91aa0a0dab
Manufacturer
UNII
PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721
  • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]
    • Quinolone Antimicrobial [EPC]
    • Quinolones [CS]
    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]

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