Dexamethasone
Approved
Approval ID
e5c28db5-efce-49a7-9e5f-12338d1f216b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 21, 2010
Manufacturers
FDA
Physicians Total Care, Inc
DUNS: 194123980
Products 6
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 Code54868-0218
Application NumberANDA084612
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2010
FDA Product Classification
INGREDIENTS (8)
DEXAMETHASONEActive
Quantity: 4 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Dexamethasone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3157
Application NumberANDA087916
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2010
FDA Product Classification
INGREDIENTS (5)
DEXAMETHASONEActive
Quantity: 2 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
Dexamethasone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0927
Application NumberANDA084611
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2010
FDA Product Classification
INGREDIENTS (7)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
DEXAMETHASONEActive
Quantity: 0.5 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Dexamethasone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0916
Application NumberANDA084613
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2010
FDA Product Classification
INGREDIENTS (6)
DEXAMETHASONEActive
Quantity: 0.75 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
Dexamethasone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-1744
Application NumberANDA084610
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2010
FDA Product Classification
INGREDIENTS (8)
DEXAMETHASONEActive
Quantity: 1.5 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
Dexamethasone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5903
Application NumberANDA088316
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2010
FDA Product Classification
INGREDIENTS (6)
DEXAMETHASONEActive
Quantity: 6 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT