NDC 42195-270

TaperDex 7-day

Dexamethasone

TaperDex 7-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 ID42195-270_00f6e8fe-d16c-4a18-ac5d-ddd4dd755e43
NDC42195-270
Product TypeHuman Prescription Drug
Proprietary NameTaperDex 7-day
Generic NameDexamethasone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-02-22
Marketing CategoryANDA / ANDA
Application NumberANDA088237
Labeler NameXspire Pharma, Llc
Substance NameDEXAMETHASONE
Active Ingredient Strength2 mg/1
Pharm ClassesCorticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 42195-270-07

1 BLISTER PACK in 1 CARTON (42195-270-07) > 27 TABLET in 1 BLISTER PACK
Marketing Start Date2019-02-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42195-270-07 [42195027007]

TaperDex 7-day TABLET
Marketing CategoryANDA
Application NumberANDA088237
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-22

Drug Details

Active Ingredients

IngredientStrength
DEXAMETHASONE1.5 mg/1

OpenFDA Data

SPL SET ID:2eeb2754-4c81-444a-a12c-56767fdbe721
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197580
  • 1869595
  • 2118835
  • Pharmacological Class

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

    NDC Crossover Matching brand name "TaperDex 7-day" or generic name "Dexamethasone"

    NDCBrand NameGeneric Name
    42195-127TaperDex 7-dayTaperDex 7-day
    42195-270TaperDex 7-dayTaperDex 7-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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