Registrants (1)

Northwind Pharmaceuticals

DUNS Number

036986393

Manufacturing Establishments (1)

Northwind Pharmaceuticals

Labeler

Northwind Pharmaceuticals

Registrant

Northwind Pharmaceuticals

DUNS Number

036986393

Products (7)

Levothyroxine Sodium

NDC Product Code

51655-513

Application Number

NDA021210

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

March 27, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

ACACIAInactive

Code: 5C5403N26OClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

LevothyroxineActive

Code: 9J765S329GClass: ACTIRQuantity: 0.137 mg in 1 1

Levothyroxine Sodium

NDC Product Code

51655-453

Application Number

NDA021210

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

March 27, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

ACACIAInactive

Code: 5C5403N26OClass: IACT

LevothyroxineActive

Code: 9J765S329GClass: ACTIRQuantity: 0.05 mg in 1 1

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

Levothyroxine Sodium

NDC Product Code

51655-687

Application Number

NDA021210

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

March 27, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

ACACIAInactive

Code: 5C5403N26OClass: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

LevothyroxineActive

Code: 9J765S329GClass: ACTIRQuantity: 0.075 mg in 1 1

Levothyroxine Sodium

NDC Product Code

51655-705

Application Number

NDA021210

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

March 27, 2023

Ingredients

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

ACACIAInactive

Code: 5C5403N26OClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

LevothyroxineActive

Code: 9J765S329GClass: ACTIRQuantity: 0.088 mg in 1 1

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

Levothyroxine Sodium

NDC Product Code

51655-696

Application Number

NDA021210

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

March 27, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

ACACIAInactive

Code: 5C5403N26OClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

LevothyroxineActive

Code: 9J765S329GClass: ACTIRQuantity: 0.125 mg in 1 1

Levothyroxine Sodium

NDC Product Code

51655-557

Application Number

NDA021210

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

March 27, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

ACACIAInactive

Code: 5C5403N26OClass: IACT

D&C RED NO. 27Inactive

Code: 2LRS185U6KClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

LevothyroxineActive

Code: 9J765S329GClass: ACTIRQuantity: 0.112 mg in 1 1

Levothyroxine Sodium

NDC Product Code

51655-694

Application Number

NDA021210

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

March 27, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

ACACIAInactive

Code: 5C5403N26OClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

LevothyroxineActive

Code: 9J765S329GClass: ACTIRQuantity: 0.15 mg in 1 1

Drug Labeling Information

DESCRIPTION SECTION

DESCRIPTION

Levothyroxine Sodium Tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T 4) sodium]. Synthetic T 4 is identical to that produced in the human thyroid gland. Levothyroxine (T 4) sodium has an empirical formula of C 15H 10I 4N NaO 4 • H 2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:

![Chemical Structure](/dailymed/image.cfm?name=levothyroxine-sodium-tablet- usp-jsp-1.jpg&id=706301)

Inactive Ingredients

Colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, corn starch, acacia and sodium starch glycolate. The following are the coloring additives per tablet strength:

Strength (mcg)	Color Additive(s)
25	FD&C Yellow No. 6 Aluminum Lake
50	None
75	FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake
88	D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake
100	D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake
112	D&C Red No. 27 Aluminum Lake
125	FD&C Yellow No. 6 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake
137	FD&C Blue No. 1 Aluminum Lake
150	FD&C Blue No. 2 Aluminum Lake
175	FD&C Blue No. 1 Aluminum Lake, D&C Red No. 27 Aluminum Lake
200	FD&C Red No. 40 Aluminum Lake
300	D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake

HOW SUPPLIED SECTION

HOW SUPPLIED

Levothyroxine Sodium Tablets, USP are round, color coded, partial bisected tablets debossed with JSP and ID Number:

Strength (mcg)	Color	NDC# for bottles of 30
50	White	NDC 51655-453-52
75	Purple	NDC 51655-687-52
88	Olive	NDC 51655-705-52
112	Rose	NDC 51655-557-52
125	Tan	NDC 51655-696-52
137	Blue	NDC 51655-513-52
150	Light Blue	NDC 51655-694-52

STORAGE CONDITIONS

20°C to 25°C (68°F to 77°F) with excursions between 15°C to 30°C (59°F to 86°F)

Rx only

Manufactured for:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Manufactured by:

Jerome Stevens Pharmaceuticals, Inc.

Bohemia, NY 11716

Rev. 10/18

MG #18326

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Levothyroxine Sodium

Registrants (1)

Manufacturing Establishments (1)

Products (7)

Levothyroxine Sodium

Levothyroxine Sodium

Levothyroxine Sodium

Levothyroxine Sodium

Levothyroxine Sodium

Levothyroxine Sodium

Levothyroxine Sodium

Drug Labeling Information

DESCRIPTION SECTION

DESCRIPTION

Inactive Ingredients

HOW SUPPLIED SECTION

HOW SUPPLIED