MedPath

DEXAMETHASONE

Dexamethasone

Approved
Approval ID

3ff06262-4c6f-4423-99fa-b4d8191ea133

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 17, 2020

Manufacturers
FDA

Direct Rx

DUNS: 079254320

Products 2

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 Code61919-269
Application NumberANDA088237
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateJune 17, 2020
FDA Product Classification

INGREDIENTS (7)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DEXAMETHASONEActive
Quantity: 1.5 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

DEXAMETHASONE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code61919-827
Application NumberANDA084610
Product Classification
M
Marketing Category
C73584
G
Generic Name
DEXAMETHASONE
Product Specifications
Route of AdministrationORAL
Effective DateJune 17, 2020
FDA Product Classification

INGREDIENTS (8)

FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
DEXAMETHASONEActive
Quantity: 1.5 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB

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DEXAMETHASONE - FDA Drug Approval Details