TaperDex 12-day
TaperDex 12-day DEXAMETHASONE TABLETS USP, 1.5 mg Rx Only
Approved
Approval ID
d66e36d3-f6f8-4fa8-84fb-7717463e37b3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2019
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DEXAMETHASONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71205-013
Application NumberANDA088237
Product Classification
M
Marketing Category
C73584
G
Generic Name
DEXAMETHASONE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2018
FDA Product Classification
INGREDIENTS (7)
DEXAMETHASONEActive
Quantity: 1.5 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT