Levothyroxine Sodium
Levothyroxine Sodium Tablets, USP
c968836a-f94c-4d13-e053-2995a90a8df5
HUMAN PRESCRIPTION DRUG LABEL
Mar 27, 2023
Northwind Pharmaceuticals
DUNS: 036986393
Products 7
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levothyroxine Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (10)
Levothyroxine Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (8)
Levothyroxine Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
Levothyroxine Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (12)
Levothyroxine Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (12)
Levothyroxine Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (10)
Levothyroxine Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (10)
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:
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