LEVOTHYROXINE SODIUM- levothyroxine sodium tablet
AbbVie Inc.

----------

DESCRIPTION

SYNTHROID®

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

WARNINGS

CAUTION: FOR MANUFACTURING, PROCESSING, OR REPACKAGING

PERISHABLE

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

NDC 0074-0020-22

SYNTHROID 25® MCG

FOR EXPORT ONLY

Knoll LLC

Road 144 km 2,6

Jayuya, PR 00664

NDC 0074-0021-22

SYNTHROID 50® MCG

FOR EXPORT ONLY

Knoll LLC

Road 144 km 2,6

Jayuya, PR 00664

NDC 0074-0022-22

SYNTHROID 75® MCG

FOR EXPORT ONLY

Knoll LLC

Road 144 km 2,6

Jayuya, PR 00664

NDC 0074-0023-22

SYNTHROID 88® MCG

FOR EXPORT ONLY

Knoll LLC

Road 144 km 2,6

Jayuya, PR 00664

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

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

LEVOTHYROXINE SODIUM
levothyroxine sodium tablet

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC:0074-0020
Route of Administration	NOT APPLICABLE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE SODIUM ANHYDROUS	25 ug

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0074-0020-22	99009 in 1 PAIL

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE SODIUM ANHYDROUS	50 ug

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0074-0021-22	99009 in 1 PAIL

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE SODIUM ANHYDROUS	75 ug

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0074-0022-22	99009 in 1 PAIL

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE SODIUM ANHYDROUS	88 ug

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0074-0023-22	99009 in 1 PAIL

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE SODIUM ANHYDROUS	100 ug

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0074-0025-22	99009 in 1 PAIL

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE SODIUM ANHYDROUS	112 ug

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0074-0026-22	99009 in 1 PAIL

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE SODIUM ANHYDROUS	125 ug

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0074-0027-22	99009 in 1 PAIL

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE SODIUM ANHYDROUS	137 ug

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0074-0028-22	99009 in 1 PAIL

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE SODIUM ANHYDROUS	150 ug

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0074-0029-22	99009 in 1 PAIL

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE SODIUM ANHYDROUS	175 ug

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0074-0031-22	99009 in 1 PAIL

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE SODIUM ANHYDROUS	200 ug

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0074-0032-22	99009 in 1 PAIL

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Export only		07/22/2015

Labeler - AbbVie Inc. (078458370)

Revised: 8/2015

Document Id: b2cdba83-728d-4b4c-6263-7991a657d62b

Set id: 2814fc0b-84ac-9f7b-5845-797d3d6d835b

Version: 2

Effective Time: 20150818

AbbVie Inc.