NDC 42195-221

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 ID42195-221_5bf9e180-2855-45ca-8d9a-d1fd752bf90c
NDC42195-221
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 Through2021-12-31

Packaging

NDC 42195-221-06

1 BLISTER PACK in 1 CARTON (42195-221-06) > 21 TABLET in 1 BLISTER PACK
Marketing Start Date2018-01-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42195-221-06 [42195022106]

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

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.