MedPath

Dexamethasone

Dexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP ™ (Concentrate)

Approved
Approval ID

a7380e36-e274-4d03-b172-869b72645f7b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 23, 2018

Manufacturers
FDA

Aidarex Pharmaceuticals LLC

DUNS: 801503249

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Dexamethasone

PRODUCT DETAILS

NDC Product Code53217-374
Application NumberANDA084612
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 23, 2018
Generic NameDexamethasone

INGREDIENTS (8)

FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
DEXAMETHASONEActive
Quantity: 4 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
© Copyright 2025. All Rights Reserved by MedPath
Dexamethasone - FDA Approval | MedPath