Levothyroxine sodium tablet

Ingredients and appearance - Product information

Levothyroxine sodium tablet- Levothyroxine sodium

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 63187-459
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Levothyroxine sodium ( UNII: 9J765S329G)( Levothyroxine - UNII: Q51BO43MG4 ) 0.05 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Lactose, unspecified form ( UNII: J2B2A4N98G)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Starch, corn ( UNII: O8232NY3SJ)
Acacia ( UNII: 5C5403N26O)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)

Product Characteristics

Color WHITE Size 7 mm
Shape ROUND Score 2
Imprint Code JSP;514

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA021210 USA

Levothyroxine sodium tablet- Levothyroxine sodium

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 63187-460
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Levothyroxine sodium ( UNII: 9J765S329G)( Levothyroxine - UNII: Q51BO43MG4 ) 0.1 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Lactose, unspecified form ( UNII: J2B2A4N98G)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( 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)
Aluminum oxide ( UNII: LMI26O6933)

Product Characteristics

Color YELLOW Size 7 mm
Shape ROUND Score 2
Imprint Code JSP;516

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA021210 USA

Levothyroxine sodium tablet- Levothyroxine sodium

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 63187-496
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, unspecified form ( UNII: J2B2A4N98G)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( 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) Size 7 mm
Shape ROUND Score 2
Imprint Code JSP;562

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA021210 USA

Labeler - Proficient Rx LP( 079196022)

Establishment

Name ID/FEI Business Operations
Proficient Rx LP 079196022 REPACK( 63187-459, 63187-460, 63187-496), RELABEL( 63187-459, 63187-460, 63187-496)