Levothyroxine Sodium: Package Insert and Label Information (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0480-8715-98

Levothyroxine Sodium Tablets, USP

150 mcg (0.15 mg)

Rx only

90 Tablets

Label 150 mcg, 90 Tablets
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0480-8718-98

Levothyroxine Sodium Tablets, USP

175 mcg (0.175 mg)

Rx only

90 Tablets

Label 175 mcg, 90 Tablets
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 480-8722-98

Levothyroxine Sodium Tablets, USP

200 mcg (0.2 mg)

Rx only

90 Tablets

Label 200 mcg, 90 Tablets
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0480-8725-98

Levothyroxine Sodium Tablets, USP

300 mcg (0.3 mg)

Rx only

90 Tablets

Label 300 mcg, 90 Tablets
(click image for full-size original)
LEVOTHYROXINE SODIUM levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-8682
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 25 ug
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
WATER
FD&C YELLOW NO. 6
Product Characteristics
Color orange Score 2 pieces
Shape OVAL (capsule-shaped) Size 9mm
Flavor Imprint Code 25;T;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0480-8682-98 90 TABLET in 1 BOTTLE None
2 NDC:0480-8682-01 100 TABLET in 1 BOTTLE None
3 NDC:0480-8682-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207588 09/21/2022
LEVOTHYROXINE SODIUM levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-8687
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 50 ug
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
WATER
Product Characteristics
Color white Score 2 pieces
Shape OVAL (capsule-shaped) Size 9mm
Flavor Imprint Code 50;T;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0480-8687-98 90 TABLET in 1 BOTTLE None
2 NDC:0480-8687-01 100 TABLET in 1 BOTTLE None
3 NDC:0480-8687-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207588 09/21/2022
LEVOTHYROXINE SODIUM levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-8690
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 75 ug
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
WATER
FD&C RED NO. 40
FD&C BLUE NO. 2–ALUMINUM LAKE
Product Characteristics
Color purple (Violet) Score 2 pieces
Shape OVAL (capsule-shaped) Size 9mm
Flavor Imprint Code 75;T;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0480-8690-98 90 TABLET in 1 BOTTLE None
2 NDC:0480-8690-01 100 TABLET in 1 BOTTLE None
3 NDC:0480-8690-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207588 09/21/2022
LEVOTHYROXINE SODIUM levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-8693
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 88 ug
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
WATER
FD&C BLUE NO. 2–ALUMINUM LAKE
D&C YELLOW NO. 10 ALUMINUM LAKE
FD&C YELLOW NO. 6
Product Characteristics
Color green (Olive) Score 2 pieces
Shape OVAL (capsule-shaped) Size 9mm
Flavor Imprint Code 88;T;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0480-8693-98 90 TABLET in 1 BOTTLE None
2 NDC:0480-8693-01 100 TABLET in 1 BOTTLE None
3 NDC:0480-8693-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207588 09/21/2022
LEVOTHYROXINE SODIUM levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-8701
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 100 ug
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
WATER
D&C YELLOW NO. 10 ALUMINUM LAKE
FD&C YELLOW NO. 6
Product Characteristics
Color yellow Score 2 pieces
Shape OVAL (capsule-shaped) Size 9mm
Flavor Imprint Code 100;T;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0480-8701-98 90 TABLET in 1 BOTTLE None
2 NDC:0480-8701-01 100 TABLET in 1 BOTTLE None
3 NDC:0480-8701-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207588 09/21/2022
LEVOTHYROXINE SODIUM levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-8704
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 112 ug
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
CARMINIC ACID
WATER
Product Characteristics
Color red (rose) Score 2 pieces
Shape OVAL (capsule-shaped) Size 9mm
Flavor Imprint Code 112;T;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0480-8704-98 90 TABLET in 1 BOTTLE None
2 NDC:0480-8704-01 100 TABLET in 1 BOTTLE None
3 NDC:0480-8704-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207588 09/21/2022
LEVOTHYROXINE SODIUM levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-8707
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 125 ug
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
WATER
FD&C YELLOW NO. 6
FD&C RED NO. 40
FD&C BLUE NO. 1 ALUMINUM LAKE
Product Characteristics
Color brown Score 2 pieces
Shape OVAL (capsule-shaped) Size 9mm
Flavor Imprint Code 125;T;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0480-8707-98 90 TABLET in 1 BOTTLE None
2 NDC:0480-8707-01 100 TABLET in 1 BOTTLE None
3 NDC:0480-8707-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207588 09/21/2022
LEVOTHYROXINE SODIUM levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-8710
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 137 ug
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
WATER
FD&C BLUE NO. 1 ALUMINUM LAKE
Product Characteristics
Color turquoise Score 2 pieces
Shape OVAL (capsule-shaped) Size 9mm
Flavor Imprint Code 137;T;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0480-8710-98 90 TABLET in 1 BOTTLE None
2 NDC:0480-8710-01 100 TABLET in 1 BOTTLE None
3 NDC:0480-8710-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207588 09/21/2022
LEVOTHYROXINE SODIUM levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-8715
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 150 ug
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
WATER
FD&C BLUE NO. 2–ALUMINUM LAKE
Product Characteristics
Color blue Score 2 pieces
Shape OVAL (capsule-shaped) Size 9mm
Flavor Imprint Code 150;T;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0480-8715-98 90 TABLET in 1 BOTTLE None
2 NDC:0480-8715-01 100 TABLET in 1 BOTTLE None
3 NDC:0480-8715-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207588 09/21/2022
LEVOTHYROXINE SODIUM levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-8718
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 175 ug
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
WATER
CELLULOSE, MICROCRYSTALLINE
CARMINIC ACID
FD&C BLUE NO. 1 ALUMINUM LAKE
Product Characteristics
Color purple (Lilac) Score 2 pieces
Shape OVAL (capsule-shaped) Size 9mm
Flavor Imprint Code 175;T;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0480-8718-98 90 TABLET in 1 BOTTLE None
2 NDC:0480-8718-01 100 TABLET in 1 BOTTLE None
3 NDC:0480-8718-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207588 09/21/2022
LEVOTHYROXINE SODIUM levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-8722
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 200 ug
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
WATER
FD&C RED NO. 40
Product Characteristics
Color pink Score 2 pieces
Shape OVAL (capsule-shaped) Size 9mm
Flavor Imprint Code 200;T;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0480-8722-98 90 TABLET in 1 BOTTLE None
2 NDC:0480-8722-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207588 09/21/2022
LEVOTHYROXINE SODIUM levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-8725
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 300 ug
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
WATER
FD&C YELLOW NO. 6
FD&C BLUE NO. 1 ALUMINUM LAKE
Product Characteristics
Color green Score 2 pieces
Shape OVAL (capsule-shaped) Size 9mm
Flavor Imprint Code 300;T;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0480-8725-98 90 TABLET in 1 BOTTLE None
2 NDC:0480-8725-01 100 TABLET in 1 BOTTLE None
3 NDC:0480-8725-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207588 09/21/2022
Labeler — Teva Pharmaceuticals, Inc. (022629579)

Revised: 09/2022 Teva Pharmaceuticals, Inc.

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