Levothyroxine Sodium
Approved
Approval ID
b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 19, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 7
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0668
Application NumberANDA076187
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2010
FDA Product Classification
INGREDIENTS (13)
LEVOTHYROXINE SODIUMActive
Quantity: 125 ug in 1 1
Code: 9J765S329G
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0605
Application NumberANDA076187
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2010
FDA Product Classification
INGREDIENTS (10)
LEVOTHYROXINE SODIUMActive
Quantity: 50 ug in 1 1
Code: 9J765S329G
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0279
Application NumberANDA076187
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2010
FDA Product Classification
INGREDIENTS (11)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 25 ug in 1 1
Code: 9J765S329G
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0606
Application NumberANDA076187
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2010
FDA Product Classification
INGREDIENTS (13)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 175 ug in 1 1
Code: 9J765S329G
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0608
Application NumberANDA076187
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2010
FDA Product Classification
INGREDIENTS (12)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 100 ug in 1 1
Code: 9J765S329G
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0280
Application NumberANDA076187
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2010
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 150 ug in 1 1
Code: 9J765S329G
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0607
Application NumberANDA076187
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2010
FDA Product Classification
INGREDIENTS (12)
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 75 ug in 1 1
Code: 9J765S329G
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT