NDC Code 43602-423-30 - Levothyroxine Sodium

NDC Code(s) : 43602-417-30, 43602-417-90, 43602-417-10, 43602-418-30, 43602-418-90, 43602-418-10, 43602-419-30, 43602-419-90, 43602-419-10, 43602-420-30, 43602-420-90, 43602-420-10, 43602-421-30, 43602-421-90, 43602-421-10, 43602-422-30, 43602-422-90, 43602-422-10, 43602-423-30, 43602-423-90, 43602-423-10, 43602-424-30, 43602-424-90, 43602-424-10, 43602-425-30, 43602-425-90, 43602-425-10, 43602-426-30, 43602-426-90, 43602-426-10, 43602-427-30, 43602-427-90, 43602-427-10, 43602-428-30, 43602-428-90, 43602-428-10
Packager : Ascent Pharmaceuticals, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LEVOTHYROXINE SODIUMlevothyroxine sodium TABLET

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43602-417
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM(UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE	0.025 mg

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)

Product Characteristics
Color	orange	Score	2 pieces
Shape	CAPSULE	Size	9 mm
Flavor		Imprint Code	1
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-417-30	30 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023
2	NDC:43602-417-90	90 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023
3	NDC:43602-417-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215259	01/18/2023

LEVOTHYROXINE SODIUMlevothyroxine sodium TABLET

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43602-418
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM(UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE	0.05 mg

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)

Product Characteristics
Color	white	Score	2 pieces
Shape	CAPSULE	Size	9 mm
Flavor		Imprint Code	2
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-418-30	30 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023
2	NDC:43602-418-90	90 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023
3	NDC:43602-418-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215259	01/18/2023

LEVOTHYROXINE SODIUMlevothyroxine sodium TABLET

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43602-419
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM(UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE	0.075 mg

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)

Product Characteristics
Color	purple (violet)	Score	2 pieces
Shape	CAPSULE	Size	9 mm
Flavor		Imprint Code	3
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-419-30	30 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023
2	NDC:43602-419-90	90 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023
3	NDC:43602-419-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215259	01/18/2023

LEVOTHYROXINE SODIUMlevothyroxine sodium TABLET

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43602-420
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM(UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE	0.088 mg

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)

Product Characteristics
Color	green (olive)	Score	2 pieces
Shape	CAPSULE	Size	9 mm
Flavor		Imprint Code	4
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-420-30	30 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023
2	NDC:43602-420-90	90 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023
3	NDC:43602-420-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215259	01/18/2023

LEVOTHYROXINE SODIUMlevothyroxine sodium TABLET

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43602-421
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM(UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE	0.1 mg

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)

Product Characteristics
Color	yellow	Score	2 pieces
Shape	CAPSULE	Size	9 mm
Flavor		Imprint Code	5
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-421-30	30 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023
2	NDC:43602-421-90	90 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023
3	NDC:43602-421-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215259	01/18/2023

LEVOTHYROXINE SODIUMlevothyroxine sodium TABLET

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43602-422
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM(UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE	0.112 mg

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
D&C RED NO. 27(UNII: 2LRS185U6K)
D&C RED NO. 30(UNII: 2S42T2808B)

Product Characteristics
Color	pink (rose)	Score	2 pieces
Shape	CAPSULE	Size	9 mm
Flavor		Imprint Code	6
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-422-30	30 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023
2	NDC:43602-422-90	90 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023
3	NDC:43602-422-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215259	01/18/2023

LEVOTHYROXINE SODIUMlevothyroxine sodium TABLET

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43602-423
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM(UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE	0.125 mg

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)

Product Characteristics
Color	gray	Score	2
Shape	capsule	Size	9 mm
Flavor		Imprint Code	7
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-423-30	30 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023
2	NDC:43602-423-90	90 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023
3	NDC:43602-423-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215259	01/18/2023

LEVOTHYROXINE SODIUMlevothyroxine sodium TABLET

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43602-424
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM(UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE	0.137 mg

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)

Product Characteristics
Color	turquoise	Score	2
Shape	capsule	Size	9 mm
Flavor		Imprint Code	8
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-424-30	30 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023
2	NDC:43602-424-90	90 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023
3	NDC:43602-424-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215259	01/18/2023

LEVOTHYROXINE SODIUMlevothyroxine sodium TABLET

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43602-425
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM(UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE	0.15 mg

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
povidone(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)

Product Characteristics
Color	blue	Score	2
Shape	capsule	Size	9 mm
Flavor		Imprint Code	9
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-425-30	30 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023
2	NDC:43602-425-90	90 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023
3	NDC:43602-425-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215259	01/18/2023

LEVOTHYROXINE SODIUMlevothyroxine sodium TABLET

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43602-426
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM(UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE	0.175 mg

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
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	Score	2
Shape	capsule	Size	9 mm
Flavor		Imprint Code	1;0
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-426-30	30 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023
2	NDC:43602-426-90	90 in 1 PACKAGE Type 0: Not a Combination Product	18/01/2023
3	NDC:43602-426-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215259	01/18/2023

LEVOTHYROXINE SODIUMlevothyroxine sodium TABLET

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43602-427
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM(UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE	0.2 mg

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C RED NO. 40(UNII: WZB9127XOA)

Product Characteristics
Color	pink	Score	2
Shape	capsule	Size	9 mm
Flavor		Imprint Code	1;1
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-427-30	30 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023
2	NDC:43602-427-90	90 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023
3	NDC:43602-427-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215259	01/18/2023

LEVOTHYROXINE SODIUMlevothyroxine sodium TABLET

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43602-428
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM(UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE	0.3 mg

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)

Product Characteristics
Color	green	Score	2
Shape	capsule	Size	9 mm
Flavor		Imprint Code	1;2
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-428-30	30 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023
2	NDC:43602-428-90	90 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023
3	NDC:43602-428-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	18/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215259	01/18/2023

LABELER - Ascent Pharmaceuticals, Inc(080938961)

Establishment
Name	Address	ID/FEI	Business Operations
Ascent Pharmaceuticals, Inc		080938961	manufacture(43602-417, 43602-418, 43602-419, 43602-420, 43602-421, 43602-422, 43602-423, 43602-424, 43602-425, 43602-426, 43602-427, 43602-428), analysis(43602-417, 43602-418, 43602-419, 43602-420, 43602-421, 43602-422, 43602-423, 43602-424, 43602-425, 43602-426, 43602-427, 43602-428), pack(43602-417, 43602-418, 43602-419, 43602-420, 43602-421, 43602-422, 43602-423, 43602-424, 43602-425, 43602-426, 43602-427, 43602-428)