Levothyroxine sodium tablet

Ingredients and appearance - Product information

Levothyroxine sodium tablet- Llevothyroxine sodium

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 60760-341
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Levothyroxine sodium ( UNII: 9J765S329G)( Levothyroxine - UNII: Q51BO43MG4 ) 0.025 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Lactose ( UNII: J2B2A4N98G)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Starch, corn ( UNII: O8232NY3SJ)
Acacia ( UNII: 5C5403N26O)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Aluminum oxide ( UNII: LMI26O6933)

Product Characteristics

Color orange (Peach) Imprint Code JSP;513
Score 2 Shape ROUND
Size 7 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 60760-341-30 30 in 1 BOTTLE, PLASTIC 2013/05/16
2 NDC: 60760-341-90 90 in 1 BOTTLE, PLASTIC 2013/05/16

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA021210 USA 2013/05/16

Levothyroxine sodium tablet- Levothyroxine sodium

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 60760-344
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Levothyroxine sodium ( UNII: 9J765S329G)( Levothyroxine - UNII: Q51BO43MG4 ) 0.088 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Lactose ( UNII: J2B2A4N98G)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Starch, corn ( UNII: O8232NY3SJ)
Acacia ( UNII: 5C5403N26O)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Aluminum oxide ( UNII: LMI26O6933)

Product Characteristics

Color green (Olive) Imprint Code JSP;561
Score 2 Shape ROUND
Size 7 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 60760-344-30 30 in 1 BOTTLE, PLASTIC 2013/05/16
2 NDC: 60760-344-90 90 in 1 BOTTLE, PLASTIC 2013/05/16

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA021210 USA 2013/05/16

Levothyroxine sodium tablet- Levothyroxine sodium

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 60760-346
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Levothyroxine sodium ( UNII: 9J765S329G)( Levothyroxine - UNII: Q51BO43MG4 ) 0.112 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Lactose ( UNII: J2B2A4N98G)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Starch, corn ( UNII: O8232NY3SJ)
Acacia ( UNII: 5C5403N26O)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
D&c red no. 27 ( UNII: 2LRS185U6K)
Aluminum oxide ( UNII: LMI26O6933)

Product Characteristics

Color red (Rose) Imprint Code JSP;562
Score 2 Shape ROUND
Size 7 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 60760-346-30 30 in 1 BOTTLE, PLASTIC 2013/05/16
2 NDC: 60760-346-90 90 in 1 BOTTLE, PLASTIC 2013/05/16

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA021210 USA 2013/05/16

Levothyroxine sodium tablet- Levothyroxine sodium

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 60760-340
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Levothyroxine sodium ( UNII: 9J765S329G)( Levothyroxine - UNII: Q51BO43MG4 ) 0.125 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Lactose ( UNII: J2B2A4N98G)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Starch, corn ( UNII: O8232NY3SJ)
Acacia ( UNII: 5C5403N26O)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Aluminum oxide ( UNII: LMI26O6933)

Product Characteristics

Color brown (Tan) Imprint Code JSP;519
Score 2 Shape ROUND
Size 7 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 60760-340-30 30 in 1 BOTTLE, PLASTIC 2013/05/16
2 NDC: 60760-340-90 90 in 1 BOTTLE, PLASTIC 2013/05/16

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA021210 USA 2013/05/16

Labeler - St Marys Medical Park Pharmacy( 063050751)

Establishment

Name ID/FEI Business Operations
St Marys Medical Park Pharmacy 063050751 manufacture( 60760-341, 60760-344, 60760-346, 60760-340)