Dexamethasone
Dexamethasone Tablets USP
Approved
Approval ID
2ceb3a01-f5bb-4538-b5c1-cea400901d02
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2023
Manufacturers
FDA
PD-Rx Pharmaceuticals, Inc.
DUNS: 156893695
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 Code43063-266
Application NumberANDA087916
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2023
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
DEXAMETHASONEActive
Quantity: 2 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB