NDC 42195-121

TaperDex 6-day

Dexamethasone

TaperDex 6-day is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Xspire Pharma, Llc. The primary component is Dexamethasone.

Product ID42195-121_41757ac8-d743-4c74-a3fb-5236944b4a45
NDC42195-121
Product TypeHuman Prescription Drug
Proprietary NameTaperDex 6-day
Generic NameDexamethasone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-01-19
Marketing CategoryANDA / ANDA
Application NumberANDA088237
Labeler NameXspire Pharma, Llc
Substance NameDEXAMETHASONE
Active Ingredient Strength2 mg/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42195-121-06

1 BLISTER PACK in 1 CARTON (42195-121-06) > 21 TABLET in 1 BLISTER PACK
Marketing Start Date2018-01-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42195-121-06 [42195012106]

TaperDex 6-day TABLET
Marketing CategoryANDA
Application NumberANDA088237
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-19

Drug Details

Active Ingredients

IngredientStrength
DEXAMETHASONE1.5 mg/1

OpenFDA Data

SPL SET ID:1f5481d3-1ba0-44b1-8008-6c7c1137049a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197580
  • 846192
  • 1998482
  • Pharmacological Class

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

    NDC Crossover Matching brand name "TaperDex 6-day" or generic name "Dexamethasone"

    NDCBrand NameGeneric Name
    71205-012TaperDex 6-dayTaperDex 6-day
    42195-121TaperDex 6-dayTaperDex 6-day
    42195-221TaperDex 6-dayTaperDex 6-day
    55700-854TaperDex 6-dayTaperDex 6-day
    0054-3177DexamethasoneDexamethasone
    0054-4179DexamethasoneDexamethasone
    0054-4180DexamethasoneDexamethasone
    0054-4181DexamethasoneDexamethasone
    0054-4182DexamethasoneDexamethasone
    0054-4183DexamethasoneDexamethasone
    0054-4184DexamethasoneDexamethasone
    0054-4186DexamethasoneDexamethasone
    0054-8174DexamethasoneDexamethasone
    0023-3348OZURDEXdexamethasone

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