NDC 70382-204

DEXTENZA

Dexamethasone

DEXTENZA is a Intracanalicular; Ophthalmic Insert in the Human Prescription Drug category. It is labeled and distributed by Ocular Therapeutix, Inc.. The primary component is Dexamethasone.

Product ID70382-204_58f233d6-7061-416b-a627-ac63ceb3dc8a
NDC70382-204
Product TypeHuman Prescription Drug
Proprietary NameDEXTENZA
Generic NameDexamethasone
Dosage FormInsert
Route of AdministrationINTRACANALICULAR; OPHTHALMIC
Marketing Start Date2019-01-07
Marketing CategoryNDA / NDA
Application NumberNDA208742
Labeler NameOcular Therapeutix, Inc.
Substance NameDEXAMETHASONE
Active Ingredient Strength0 mg/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70382-204-01

1 POUCH in 1 BOX, UNIT-DOSE (70382-204-01) > 1 INSERT in 1 POUCH (70382-204-88)
Marketing Start Date2019-01-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70382-204-10 [70382020410]

DEXTENZA INSERT
Marketing CategoryNDA
Application NumberNDA208742
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-07

NDC 70382-204-01 [70382020401]

DEXTENZA INSERT
Marketing CategoryNDA
Application NumberNDA208742
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-07

NDC 70382-204-99 [70382020499]

DEXTENZA INSERT
Marketing CategoryNDA
Application NumberNDA208742
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-07

NDC 70382-204-88 [70382020488]

DEXTENZA INSERT
Marketing CategoryNDA
Application NumberNDA208742
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-07

Drug Details

Active Ingredients

IngredientStrength
DEXAMETHASONE.4 mg/1

OpenFDA Data

SPL SET ID:7514e6b8-c33f-4fbf-8810-ef520e1eb4bd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2108015
  • 2108020
  • UPC Code
  • 0370382204885
  • Pharmacological Class

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

    NDC Crossover Matching brand name "DEXTENZA" or generic name "Dexamethasone"

    NDCBrand NameGeneric Name
    70382-204DEXTENZADEXTENZA
    0054-3177DexamethasoneDexamethasone
    0054-4179DexamethasoneDexamethasone
    0054-4180DexamethasoneDexamethasone
    0054-4181DexamethasoneDexamethasone
    0054-4182DexamethasoneDexamethasone
    0054-4183DexamethasoneDexamethasone
    0054-4184DexamethasoneDexamethasone
    0054-4186DexamethasoneDexamethasone
    0054-8174DexamethasoneDexamethasone
    0023-3348OZURDEXdexamethasone

    Trademark Results [DEXTENZA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DEXTENZA
    DEXTENZA
    87864954 not registered Live/Pending
    Ocular Therapeutix, Inc.
    2018-04-05
    DEXTENZA
    DEXTENZA
    86425297 5513989 Live/Registered
    Ocular Therapeutix, Inc.
    2014-10-16

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