NDC 42195-490

TaperDex 12-day

Dexamethasone

TaperDex 12-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 ID42195-490_450c31b5-c5c0-44bb-bde5-66748f67b156
NDC42195-490
Product TypeHuman Prescription Drug
Proprietary NameTaperDex 12-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 Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 42195-490-12

1 BLISTER PACK in 1 CARTON (42195-490-12) > 49 TABLET in 1 BLISTER PACK
Marketing Start Date2018-01-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42195-490-12 [42195049012]

TaperDex 12-day TABLET
Marketing CategoryANDA
Application NumberANDA088237
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-19

Drug Details

Active Ingredients

IngredientStrength
DEXAMETHASONE1.5 mg/1

OpenFDA Data

SPL SET ID:c3c59b82-1343-470d-bbc7-e40da3c0a28f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197580
  • 1998481
  • 1943550
  • Pharmacological Class

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

    NDC Crossover Matching brand name "TaperDex 12-day" or generic name "Dexamethasone"

    NDCBrand NameGeneric Name
    71205-013TaperDex 12-dayTaperDex 12-day
    42195-149TaperDex 12-dayTaperDex 12-day
    42195-490TaperDex 12-dayTaperDex 12-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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