MedPath

Dexamethasone

DEXAMETHASONE TABLETS, USP

Approved
Approval ID

f3d1f760-562f-09b2-e053-2a95a90a7f42

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 3, 2023

Manufacturers
FDA

Redpharm Drug, Inc.

DUNS: 828374897

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 Code67296-1837
Application NumberANDA088481
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateFebruary 3, 2023
Generic Namedexamethasone

INGREDIENTS (6)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
DEXAMETHASONEActive
Quantity: 4 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

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Dexamethasone - FDA Drug Approval Details