NDC Code(s) : 0378-3611-01, 0378-3612-01, 0378-3613-01
Packager : Mylan Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Liothyronine sodiumLiothyronine sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-3611
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIOTHYRONINE SODIUM(UNII: GCA9VV7D2N)
(LIOTHYRONINE - UNII:06LU7C9H1V) 		LIOTHYRONINE5 ug
Inactive Ingredients
Ingredient Name Strength
CALCIUM SULFATE ANHYDROUS(UNII: E934B3V59H)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
STARCH, CORN(UNII: O8232NY3SJ)
STEARIC ACID(UNII: 4ELV7Z65AP)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code ML;11
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-3611-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/03/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090326 10/03/2016 12/31/2018
Liothyronine sodiumLiothyronine sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-3612
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIOTHYRONINE SODIUM(UNII: GCA9VV7D2N)
(LIOTHYRONINE - UNII:06LU7C9H1V) 		LIOTHYRONINE25 ug
Inactive Ingredients
Ingredient Name Strength
CALCIUM SULFATE ANHYDROUS(UNII: E934B3V59H)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
STARCH, CORN(UNII: O8232NY3SJ)
STEARIC ACID(UNII: 4ELV7Z65AP)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape OVAL Size 8 mm
Flavor Imprint Code M;L;12
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-3612-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/03/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090326 10/03/2016 12/31/2018
Liothyronine sodiumLiothyronine sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-3613
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIOTHYRONINE SODIUM(UNII: GCA9VV7D2N)
(LIOTHYRONINE - UNII:06LU7C9H1V) 		LIOTHYRONINE50 ug
Inactive Ingredients
Ingredient Name Strength
CALCIUM SULFATE ANHYDROUS(UNII: E934B3V59H)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
STARCH, CORN(UNII: O8232NY3SJ)
STEARIC ACID(UNII: 4ELV7Z65AP)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape OVAL (caplet-shaped) Size 7 mm
Flavor Imprint Code M;L;13
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-3613-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/03/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090326 10/03/2016 05/31/2018

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 5 mcg

NDC 0378-3611-01

Liothyronine
Sodium
Tablets, USP
5 mcg

Rx only 100 Tablets

Each tablet contains liothyronine
sodium, USP equivalent to 5 mcg
of liothyronine.

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

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Usual Dosage: See accompanying
prescribing information.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

RM3611A2

Liothyronine Sodium Tablets, USP 5 mcg Bottle Labels

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 25 mcg

NDC 0378-3612-01

Liothyronine
Sodium
Tablets, USP
25 mcg

Rx only 100 Tablets

Each tablet contains liothyronine
sodium, USP equivalent to 25 mcg
of liothyronine.

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

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Usual Dosage: See accompanying
prescribing information.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

RM3612A2

Liothyronine Sodium Tablets, USP 25 mcg Bottle Labels

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 50 mcg

NDC 0378-3613-01

Liothyronine
Sodium
Tablets, USP
50 mcg

Rx only 100 Tablets

Each tablet contains liothyronine
sodium, USP equivalent to 50 mcg
of liothyronine.

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

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Usual Dosage: See accompanying
prescribing information.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

RM3613A2

Liothyronine Sodium Tablets, USP 50 mcg Bottle Labels