NDC 42195-721

DEXAMETHASONE 6-Day

Dexamethasone

DEXAMETHASONE 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 ID42195-721_16929f11-7e9f-4aab-aeef-82d5d50d66b9
NDC42195-721
Product TypeHuman Prescription Drug
Proprietary NameDEXAMETHASONE 6-Day
Generic NameDexamethasone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-05-07
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 42195-721-21

1 BLISTER PACK in 1 CARTON (42195-721-21) > 21 TABLET in 1 BLISTER PACK
Marketing Start Date2020-05-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42195-721-21 [42195072121]

DEXAMETHASONE 6-Day TABLET
Marketing CategoryANDA
Application NumberANDA088237
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-07

Drug Details

NDC Crossover Matching brand name "DEXAMETHASONE 6-Day" or generic name "Dexamethasone"

NDCBrand NameGeneric Name
42195-721DEXAMETHASONE 6-DayDEXAMETHASONE 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.