Label: LEVOTHYROXINE SODIUM- levothyroxine sodium tablet

  • NDC Code(s): 0074-0020-22, 0074-0021-22, 0074-0022-22, 0074-0023-22, view more
    0074-0025-22, 0074-0026-22, 0074-0027-22, 0074-0028-22, 0074-0029-22, 0074-0031-22, 0074-0032-22
  • Packager: AbbVie Inc.
  • Category: BULK INGREDIENT

Drug Label Information

Updated August 18, 2015

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • DESCRIPTION

    SYNTHROID®

    LEVOTHYROXINE SODIUM TABLETS 25mcg, 50mcg, 75mcg, 88mcg, 100mcg, 112mcg, 125mcg, 137mcg, 150mcg, 175mcg, 200mcg

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  • WARNINGS

    CAUTION: FOR MANUFACTURING, PROCESSING, OR REPACKAGING

    PERISHABLE

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  • HOW SUPPLIED

    Packaged in pails

    Maximum weight: 13 kilograms per pail

    Storage

    STORE AT ROOM TEMPERATURE (15-30oC)

    PROTECT FROM LIGHT AND MOISTURE.

    FOR EXPORT ONLY

    ABBOTT LABORATORIES OF BRAZIL, RIO DE JANEIRO

    MANUFACTURER: Knoll LLC Road 144 km 2,6 Jayuya, PR 00664

    EXPORTER: Abbott Logistics B.V. Meeuwenlaan 4 8011 BZ Zwolle, Netherlands

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  • PRINCIPAL DISPLAY PANEL

    NDC 0074-0020-22

    SYNTHROID 25® MCG

    FOR EXPORT ONLY

    Knoll LLC

    Road 144 km 2,6

    Jayuya, PR 00664

    0074-0020-22 levothyroxine-sodium-25mcg

    NDC 0074-0021-22

    SYNTHROID 50® MCG

    FOR EXPORT ONLY

    Knoll LLC

    Road 144 km 2,6

    Jayuya, PR 00664

    0074-0021-22 levothyroxine-sodium-50mcg

    NDC 0074-0022-22

    SYNTHROID 75® MCG

    FOR EXPORT ONLY

    Knoll LLC

    Road 144 km 2,6

    Jayuya, PR 00664

    0074-0022-22 levothyroxine-sodium-75mcg

    NDC 0074-0023-22

    SYNTHROID 88® MCG

    FOR EXPORT ONLY

    Knoll LLC

    Road 144 km 2,6

    Jayuya, PR 00664

    0074-0023-22 levothyroxine-sodium-88mcg

    NDC 0074-0025-22

    SYNTHROID 100® MCG

    FOR EXPORT ONLY

    Knoll LLC

    Road 144 km 2,6

    Jayuya, PR 00664

    0074-0025-22 levothyroxine-sodium-100mcg

    NDC 0074-0026-22

    SYNTHROID 112® MCG

    FOR EXPORT ONLY

    Knoll LLC

    Road 144 km 2,6

    Jayuya, PR 00664

    0074-0026-22 levothyroxine-sodium-112mcg

    NDC 0074-0027-22

    SYNTHROID 125® MCG

    FOR EXPORT ONLY

    Knoll LLC

    Road 144 km 2,6

    Jayuya, PR 00664

    0074-0027-22 levothyroxine-sodium-125mcg

    NDC 0074-0028-22

    SYNTHROID 137® MCG

    FOR EXPORT ONLY

    Knoll LLC

    Road 144 km 2,6

    Jayuya, PR 00664

    0074-028-22 levothyroxine-sodium-137mcg

    NDC 0074-0029-22

    SYNTHROID 150® MCG

    FOR EXPORT ONLY

    Knoll LLC

    Road 144 km 2,6

    Jayuya, PR 00664

    0074-0029-22 levothyroxine-sodium-150mcg

    NDC 0074-0031-22

    SYNTHROID 175® MCG

    FOR EXPORT ONLY

    Knoll LLC

    Road 144 km 2,6

    Jayuya, PR 00664

    0074-0031-22 levothyroxine-sodium-175mcg

    NDC 0074-0032-22

    SYNTHROID 200® MCG

    FOR EXPORT ONLY

    Knoll LLC

    Road 144 km 2,6

    Jayuya, PR 00664

    0074-0032-22 levothyroxine-sodium-200mcg
    Close
  • INGREDIENTS AND APPEARANCE
    LEVOTHYROXINE SODIUM 
    levothyroxine sodium tablet
    Product Information
    Product Type BULK INGREDIENT Item Code (Source) NDC:0074-0020
    Route of Administration NOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS 25 ug
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA (UNII: 5C5403N26O)  
    SUCROSE (UNII: C151H8M554)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POVIDONES (UNII: FZ989GH94E)  
    Product Characteristics
    Color ORANGE Score 2 pieces
    Shape ROUND Size 7mm
    Flavor Imprint Code 25
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0074-0020-22 99009 in 1 PAIL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Export only 07/22/2015
    LEVOTHYROXINE SODIUM 
    levothyroxine sodium tablet
    Product Information
    Product Type BULK INGREDIENT Item Code (Source) NDC:0074-0021
    Route of Administration NOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS 50 ug
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA (UNII: 5C5403N26O)  
    SUCROSE (UNII: C151H8M554)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    POVIDONES (UNII: FZ989GH94E)  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape ROUND Size 7mm
    Flavor Imprint Code 50
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0074-0021-22 99009 in 1 PAIL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Export only 07/22/2015
    LEVOTHYROXINE SODIUM 
    levothyroxine sodium tablet
    Product Information
    Product Type BULK INGREDIENT Item Code (Source) NDC:0074-0022
    Route of Administration NOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS 75 ug
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA (UNII: 5C5403N26O)  
    SUCROSE (UNII: C151H8M554)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POVIDONES (UNII: FZ989GH94E)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    Product Characteristics
    Color PURPLE (VIOLET) Score 2 pieces
    Shape ROUND Size 7mm
    Flavor Imprint Code 75
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0074-0022-22 99009 in 1 PAIL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Export only 07/22/2015
    LEVOTHYROXINE SODIUM 
    levothyroxine sodium tablet
    Product Information
    Product Type BULK INGREDIENT Item Code (Source) NDC:0074-0023
    Route of Administration NOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS 88 ug
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA (UNII: 5C5403N26O)  
    SUCROSE (UNII: C151H8M554)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    POVIDONES (UNII: FZ989GH94E)  
    Product Characteristics
    Color GREEN (OLIVE) Score 2 pieces
    Shape ROUND Size 7mm
    Flavor Imprint Code 88
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0074-0023-22 99009 in 1 PAIL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Export only 07/22/2015
    LEVOTHYROXINE SODIUM 
    levothyroxine sodium tablet
    Product Information
    Product Type BULK INGREDIENT Item Code (Source) NDC:0074-0025
    Route of Administration NOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS 100 ug
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA (UNII: 5C5403N26O)  
    SUCROSE (UNII: C151H8M554)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    POVIDONES (UNII: FZ989GH94E)  
    Product Characteristics
    Color YELLOW Score 2 pieces
    Shape ROUND Size 7mm
    Flavor Imprint Code 100
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0074-0025-22 99009 in 1 PAIL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Export only 07/22/2015
    LEVOTHYROXINE SODIUM 
    levothyroxine sodium tablet
    Product Information
    Product Type BULK INGREDIENT Item Code (Source) NDC:0074-0026
    Route of Administration NOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS 112 ug
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA (UNII: 5C5403N26O)  
    SUCROSE (UNII: C151H8M554)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    POVIDONES (UNII: FZ989GH94E)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    Product Characteristics
    Color RED (ROSE) Score 2 pieces
    Shape ROUND Size 7mm
    Flavor Imprint Code 112
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0074-0026-22 99009 in 1 PAIL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Export only 07/22/2015
    LEVOTHYROXINE SODIUM 
    levothyroxine sodium tablet
    Product Information
    Product Type BULK INGREDIENT Item Code (Source) NDC:0074-0027
    Route of Administration NOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS 125 ug
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA (UNII: 5C5403N26O)  
    SUCROSE (UNII: C151H8M554)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    POVIDONES (UNII: FZ989GH94E)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color BROWN Score 2 pieces
    Shape ROUND Size 7mm
    Flavor Imprint Code 125
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0074-0027-22 99009 in 1 PAIL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Export only 07/22/2015
    LEVOTHYROXINE SODIUM 
    levothyroxine sodium tablet
    Product Information
    Product Type BULK INGREDIENT Item Code (Source) NDC:0074-0028
    Route of Administration NOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS 137 ug
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA (UNII: 5C5403N26O)  
    SUCROSE (UNII: C151H8M554)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    POVIDONES (UNII: FZ989GH94E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color BLUE (TURQUOISE) Score 2 pieces
    Shape ROUND Size 7mm
    Flavor Imprint Code 137
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0074-0028-22 99009 in 1 PAIL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Export only 07/22/2015
    LEVOTHYROXINE SODIUM 
    levothyroxine sodium tablet
    Product Information
    Product Type BULK INGREDIENT Item Code (Source) NDC:0074-0029
    Route of Administration NOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS 150 ug
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA (UNII: 5C5403N26O)  
    SUCROSE (UNII: C151H8M554)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    POVIDONES (UNII: FZ989GH94E)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    Product Characteristics
    Color BLUE Score 2 pieces
    Shape ROUND Size 7mm
    Flavor Imprint Code 150
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0074-0029-22 99009 in 1 PAIL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Export only 07/22/2015
    LEVOTHYROXINE SODIUM 
    levothyroxine sodium tablet
    Product Information
    Product Type BULK INGREDIENT Item Code (Source) NDC:0074-0031
    Route of Administration NOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS 175 ug
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA (UNII: 5C5403N26O)  
    SUCROSE (UNII: C151H8M554)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    POVIDONES (UNII: FZ989GH94E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    Product Characteristics
    Color PURPLE (LILAC) Score 2 pieces
    Shape ROUND Size 7mm
    Flavor Imprint Code 175
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0074-0031-22 99009 in 1 PAIL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Export only 07/22/2015
    LEVOTHYROXINE SODIUM 
    levothyroxine sodium tablet
    Product Information
    Product Type BULK INGREDIENT Item Code (Source) NDC:0074-0032
    Route of Administration NOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS 200 ug
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA (UNII: 5C5403N26O)  
    SUCROSE (UNII: C151H8M554)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    POVIDONES (UNII: FZ989GH94E)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Color PINK Score 2 pieces
    Shape ROUND Size 7mm
    Flavor Imprint Code 200
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0074-0032-22 99009 in 1 PAIL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Export only 07/22/2015
    Labeler - AbbVie Inc. (078458370)
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