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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM(UNII: 9J765S329G)
(LEVOTHYROXINE - UNII:Q51BO43MG4) 		LEVOTHYROXINE0.025 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-417-3030 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
2NDC:43602-417-9090 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
3NDC:43602-417-101000 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM(UNII: 9J765S329G)
(LEVOTHYROXINE - UNII:Q51BO43MG4) 		LEVOTHYROXINE0.05 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-418-3030 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
2NDC:43602-418-9090 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
3NDC:43602-418-101000 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM(UNII: 9J765S329G)
(LEVOTHYROXINE - UNII:Q51BO43MG4) 		LEVOTHYROXINE0.075 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-419-3030 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
2NDC:43602-419-9090 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
3NDC:43602-419-101000 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM(UNII: 9J765S329G)
(LEVOTHYROXINE - UNII:Q51BO43MG4) 		LEVOTHYROXINE0.088 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-420-3030 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
2NDC:43602-420-9090 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
3NDC:43602-420-101000 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM(UNII: 9J765S329G)
(LEVOTHYROXINE - UNII:Q51BO43MG4) 		LEVOTHYROXINE0.1 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-421-3030 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
2NDC:43602-421-9090 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
3NDC:43602-421-101000 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM(UNII: 9J765S329G)
(LEVOTHYROXINE - UNII:Q51BO43MG4) 		LEVOTHYROXINE0.112 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-422-3030 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
2NDC:43602-422-9090 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
3NDC:43602-422-101000 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM(UNII: 9J765S329G)
(LEVOTHYROXINE - UNII:Q51BO43MG4) 		LEVOTHYROXINE0.125 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-423-3030 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
2NDC:43602-423-9090 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
3NDC:43602-423-101000 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM(UNII: 9J765S329G)
(LEVOTHYROXINE - UNII:Q51BO43MG4) 		LEVOTHYROXINE0.137 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-424-3030 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
2NDC:43602-424-9090 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
3NDC:43602-424-101000 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM(UNII: 9J765S329G)
(LEVOTHYROXINE - UNII:Q51BO43MG4) 		LEVOTHYROXINE0.15 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-425-3030 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
2NDC:43602-425-9090 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
3NDC:43602-425-101000 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM(UNII: 9J765S329G)
(LEVOTHYROXINE - UNII:Q51BO43MG4) 		LEVOTHYROXINE0.175 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-426-3030 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
2NDC:43602-426-9090 in 1 PACKAGE Type 0: Not a Combination Product18/01/2023
3NDC:43602-426-101000 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM(UNII: 9J765S329G)
(LEVOTHYROXINE - UNII:Q51BO43MG4) 		LEVOTHYROXINE0.2 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-427-3030 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
2NDC:43602-427-9090 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
3NDC:43602-427-101000 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM(UNII: 9J765S329G)
(LEVOTHYROXINE - UNII:Q51BO43MG4) 		LEVOTHYROXINE0.3 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-428-3030 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
2NDC:43602-428-9090 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
3NDC:43602-428-101000 in 1 BOTTLE Type 0: Not a Combination Product18/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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)

PRINCIPAL DISPLAY PANEL

25mcg

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25mcg

25mcg

25mcg