NDC 53217-310

Dexamethasone

Dexamethasone

Dexamethasone is a Oral Elixir in the Human Prescription Drug category. It is labeled and distributed by Aidarex Pharmaceuticals Llc. The primary component is Dexamethasone.

Product ID53217-310_be5921e9-99ec-47c5-af90-5ef03b4e8c33
NDC53217-310
Product TypeHuman Prescription Drug
Proprietary NameDexamethasone
Generic NameDexamethasone
Dosage FormElixir
Route of AdministrationORAL
Marketing Start Date2017-05-19
Marketing CategoryANDA / ANDA
Application NumberANDA084754
Labeler NameAidarex Pharmaceuticals LLC
Substance NameDEXAMETHASONE
Active Ingredient Strength1 mg/5mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53217-310-01

237 mL in 1 BOTTLE, GLASS (53217-310-01)
Marketing Start Date2017-05-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53217-310-01 [53217031001]

Dexamethasone ELIXIR
Marketing CategoryANDA
Application NumberANDA084754
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-05-19
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DEXAMETHASONE.5 mg/5mL

OpenFDA Data

SPL SET ID:4f6e8fd1-d3c5-46a3-b6ca-0748bfc59030
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309686
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0054-3177DexamethasoneDexamethasone
    0054-4179DexamethasoneDexamethasone
    0054-4180DexamethasoneDexamethasone
    0054-4181DexamethasoneDexamethasone
    0054-4182DexamethasoneDexamethasone
    0054-4183DexamethasoneDexamethasone
    0054-4184DexamethasoneDexamethasone
    0054-4186DexamethasoneDexamethasone
    0054-8174DexamethasoneDexamethasone
    68071-4127DexamethasoneDexamethasone
    68788-7142DexamethasoneDexamethasone
    68788-7267DexamethasoneDexamethasone
    68788-9939DexamethasoneDexamethasone
    68788-9938DexamethasoneDexamethasone
    0054-8176DexamethasoneDexamethasone
    0054-8181DexamethasoneDexamethasone
    0054-8183DexamethasoneDexamethasone
    0054-8180DexamethasoneDexamethasone
    0054-8175DexamethasoneDexamethasone
    0054-8179DexamethasoneDexamethasone
    70518-0843DexamethasoneDexamethasone
    70518-1534DexamethasoneDexamethasone
    71335-0177DexamethasoneDexamethasone
    71335-0077DexamethasoneDexamethasone
    10544-211DexamethasoneDexamethasone
    10544-212DexamethasoneDexamethasone
    0095-0089DexamethasoneDexamethasone
    0095-0088DexamethasoneDexamethasone
    0095-0087DexamethasoneDexamethasone
    21695-382DexamethasoneDexamethasone
    21695-290DexamethasoneDexamethasone
    21695-728DexamethasoneDexamethasone
    21695-745DexamethasoneDexamethasone
    33261-625DexamethasoneDexamethasone
    42195-151DexamethasoneDexamethasone
    43063-266DexamethasoneDexamethasone
    48102-048DexamethasoneDexamethasone
    48102-047DexamethasoneDexamethasone
    48102-046DexamethasoneDexamethasone
    48102-045DexamethasoneDexamethasone
    49999-059DexamethasoneDexamethasone
    49884-085DexamethasoneDexamethasone
    49884-086DexamethasoneDexamethasone
    49884-087DexamethasoneDexamethasone
    49884-373DexamethasoneDexamethasone
    49884-084DexamethasoneDexamethasone
    50090-0091DexamethasoneDexamethasone
    50090-0090DexamethasoneDexamethasone
    50090-0088DexamethasoneDexamethasone
    50090-0089DexamethasoneDexamethasone

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