Levothyroxine Sodium (Page 6 of 8)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenicity studies in animals to evaluate the carcinogenic potential of levothyroxine have not been performed. Studies to evaluate mutagenic potential and animal fertility have not been performed.

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Levothyroxine sodium tablets, USP are flat, beveled edge capsule shaped scored tablets and are supplied as follows (Table 11):

Table 11: Levothyroxine Sodium Tablets, USP Presentations

Strength

Color/Shape

Debossed Tablet Markings

NDC # for bottles of 90

NDC # for bottles of 100

NDC # for bottles of 1000

25 mcg

Orange/ Capsule Shaped

25 on the unscored side and T bisect V on the scored side, with side scores

0480-8682-98

0480-8682-01

0480-8682-10

50 mcg

White/ Capsule Shaped

50 on the unscored side and T bisect V on the scored side, with side scores

0480-8687-98

0480-8687-01

0480-8687-10

75 mcg

Violet/ Capsule Shaped

75 on the unscored side and T bisect V on the scored side, with side scores

0480-8690-98

0480-8690-01

0480-8690-10

88 mcg

Olive/ Capsule Shaped

88 on the unscored side and T bisect V on the scored side, with side scores

0480-8693-98

0480-8693-01

0480-8693-10

100 mcg

Yellow/ Capsule Shaped

100 on the unscored side and T bisect V on the scored side, with side scores

0480-8701-98

0480-8701-01

0480-8701-10

112 mcg

Rose/ Capsule Shaped

112 on the unscored side and T bisect V on the scored side, with side scores

0480-8704-98

0480-8704-01

0480-8704-10

125 mcg

Brown/ Capsule Shaped

125 on the unscored side and T bisect V on the scored side, with side scores

0480-8707-98

0480-8707-01

0480-8707-10

137 mcg

Turquoise/ Capsule Shaped

137 on the unscored side and T bisect V on the scored side, with side scores

0480-8710-98

0480-8710-01

0480-8710-10

150 mcg

Blue/ Capsule Shaped

150 on the unscored side and T bisect V on the scored side, with side scores

0480-8715-98

0480-8715-01

0480-8715-10

175 mcg

Lilac/ Capsule Shaped

175 on the unscored side and T bisect V on the scored side, with side scores

0480-8718-98

0480-8718-01

0480-8718-10

200 mcg

Pink/ Capsule Shaped

200 on the unscored side and T bisect V on the scored side, with side scores

0480-8722-98

0480-8722-01

0480-8722-10

300 mcg

Green/ Capsule Shaped

300 on the unscored side and T bisect V on the scored side, with side scores

0480-8725-98

0480-8725-01

0480-8725-10

Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP.

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