NDC 0998-0615

Maxidex

Dexamethasone

Maxidex is a Ophthalmic Suspension in the Human Prescription Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Dexamethasone.

Product ID0998-0615_52cf7e89-eadd-4dc4-b1d5-8a36e2dc237c
NDC0998-0615
Product TypeHuman Prescription Drug
Proprietary NameMaxidex
Generic NameDexamethasone
Dosage FormSuspension
Route of AdministrationOPHTHALMIC
Marketing Start Date1966-05-15
Marketing CategoryNDA / NDA
Application NumberNDA013422
Labeler NameAlcon Laboratories, Inc.
Substance NameDEXAMETHASONE
Active Ingredient Strength1 mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0998-0615-05

5 mL in 1 BOTTLE, PLASTIC (0998-0615-05)
Marketing Start Date1966-05-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0998-0615-05 [00998061505]

Maxidex SUSPENSION
Marketing CategoryNDA
Application NumberNDA013422
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1966-05-15

Drug Details

Active Ingredients

IngredientStrength
DEXAMETHASONE1 mg/mL

OpenFDA Data

SPL SET ID:ecd69437-dd1a-453b-991d-5c5f277a3abd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205669
  • 309692

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0998-0615MaxidexMaxidex
    0054-3177DexamethasoneDexamethasone
    0054-4179DexamethasoneDexamethasone
    0054-4180DexamethasoneDexamethasone
    0054-4181DexamethasoneDexamethasone
    0054-4182DexamethasoneDexamethasone
    0054-4183DexamethasoneDexamethasone
    0054-4184DexamethasoneDexamethasone
    0054-4186DexamethasoneDexamethasone
    0054-8174DexamethasoneDexamethasone
    0023-3348OZURDEXdexamethasone

    Trademark Results [Maxidex]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MAXIDEX
    MAXIDEX
    90274189 not registered Live/Pending
    ATG Ceylon (Pvt) Limited
    2020-10-23
    MAXIDEX
    MAXIDEX
    85164978 not registered Dead/Abandoned
    ATG Ceylon (PVT) Limited
    2010-10-29
    MAXIDEX
    MAXIDEX
    72150144 0750424 Live/Registered
    Alcon Laboratories, Inc.
    1962-07-31
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.