NDC 70261-505

Pred-Brom

Prednisolone Acetate-bromfenac

Pred-Brom is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Imprimisrx Nj. The primary component is Bromfenac; Prednisolone Acetate.

Product ID70261-505_66638e3d-e2aa-e7c5-e053-2a91aa0ae8c0
NDC70261-505
Product TypeHuman Prescription Drug
Proprietary NamePred-Brom
Generic NamePrednisolone Acetate-bromfenac
Dosage FormSuspension/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2018-02-01
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameImprimisRx NJ
Substance NameBROMFENAC; PREDNISOLONE ACETATE
Active Ingredient Strength1 mg/mL; mg/mL
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70261-505-03

3.5 mL in 1 BOTTLE, DROPPER (70261-505-03)
Marketing Start Date2018-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70261-505-03 [70261050503]

Pred-Brom SUSPENSION/ DROPS
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BROMFENAC.75 mg/mL

OpenFDA Data

SPL SET ID:66638e3d-e2a9-e7c5-e053-2a91aa0ae8c0
Manufacturer
UNII
PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Pred-Brom" or generic name "Prednisolone Acetate-bromfenac"

    NDCBrand NameGeneric Name
    70261-505Pred-BromPrednisolone Acetate-Bromfenac
    71384-505Pred-BromPrednisolone Acetate-Bromfenac

    Trademark Results [Pred-Brom]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PRED-BROM
    PRED-BROM
    87731119 5577593 Live/Registered
    HARROW IP, LLC
    2017-12-21

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