NDC Code(s) : 0456-0457-01, 0456-1045-01, 0456-0458-01, 0456-0458-11, 0456-0458-63, 0456-0459-01, 0456-0459-11, 0456-0459-63, 0456-0460-01, 0456-0461-01, 0456-0461-11, 0456-0461-63, 0456-0462-01, 0456-0463-01, 0456-0464-01
Packager : Allergan, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Armour ThyroidTHYROID, PORCINE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-0457
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUS SCROFA THYROID(UNII: 6RV024OAUQ)
(SUS SCROFA THYROID - UNII:6RV024OAUQ) 		SUS SCROFA THYROID15 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE(UNII: 776XM7047L)
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
Product Characteristics
Color brown (light tan) Score no score
Shape ROUND (ROUND) Size 5 mm
Flavor Imprint Code A;TC
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0456-0457-01100 in 1 BOTTLE Type 0: Not a Combination Product04/01/1996
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/01/1996
Armour ThyroidTHYROID, PORCINE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-1045
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUS SCROFA THYROID(UNII: 6RV024OAUQ)
(SUS SCROFA THYROID - UNII:6RV024OAUQ) 		SUS SCROFA THYROID15 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE(UNII: 776XM7047L)
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
Product Characteristics
Color brown (light tan) Score no score
Shape ROUND (ROUND) Size 5 mm
Flavor Imprint Code A;TC
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0456-1045-01100 in 1 BOTTLE Type 0: Not a Combination Product04/01/1996
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/01/1996
Armour ThyroidTHYROID, PORCINE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-0458
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUS SCROFA THYROID(UNII: 6RV024OAUQ)
(SUS SCROFA THYROID - UNII:6RV024OAUQ) 		SUS SCROFA THYROID30 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE(UNII: 776XM7047L)
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
Product Characteristics
Color brown (light tan) Score no score
Shape ROUND (ROUND) Size 6 mm
Flavor Imprint Code A;TD
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0456-0458-01100 in 1 BOTTLE Type 0: Not a Combination Product04/01/1996
2NDC:0456-0458-6310 in 1 BOX, UNIT-DOSE 04/01/1996
2NDC:0456-0458-1110 in 1 BLISTER PACK Type 0: Not a Combination Product04/01/1996
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/01/1996
Armour ThyroidTHYROID, PORCINE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-0459
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUS SCROFA THYROID(UNII: 6RV024OAUQ)
(SUS SCROFA THYROID - UNII:6RV024OAUQ) 		SUS SCROFA THYROID60 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE(UNII: 776XM7047L)
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
Product Characteristics
Color brown (light tan) Score no score
Shape ROUND (ROUND) Size 7 mm
Flavor Imprint Code A;TE
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0456-0459-01100 in 1 BOTTLE Type 0: Not a Combination Product04/01/1996
2NDC:0456-0459-6310 in 1 BOX, UNIT-DOSE 04/01/1996
2NDC:0456-0459-1110 in 1 BLISTER PACK Type 0: Not a Combination Product04/01/1996
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/01/1996
Armour ThyroidTHYROID, PORCINE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-0460
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUS SCROFA THYROID(UNII: 6RV024OAUQ)
(SUS SCROFA THYROID - UNII:6RV024OAUQ) 		SUS SCROFA THYROID90 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE(UNII: 776XM7047L)
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
Product Characteristics
Color brown (light tan) Score no score
Shape ROUND (ROUND) Size 9 mm
Flavor Imprint Code A;TJ
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0456-0460-01100 in 1 BOTTLE Type 0: Not a Combination Product04/01/1996
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/01/1996
Armour ThyroidTHYROID, PORCINE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-0461
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUS SCROFA THYROID(UNII: 6RV024OAUQ)
(SUS SCROFA THYROID - UNII:6RV024OAUQ) 		SUS SCROFA THYROID120 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE(UNII: 776XM7047L)
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
Product Characteristics
Color brown (light tan) Score no score
Shape ROUND (ROUND) Size 10 mm
Flavor Imprint Code A;TF
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0456-0461-01100 in 1 BOTTLE Type 0: Not a Combination Product04/01/1996
2NDC:0456-0461-6310 in 1 BOX, UNIT-DOSE 04/01/1996
2NDC:0456-0461-1110 in 1 BLISTER PACK Type 0: Not a Combination Product04/01/1996
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/01/1996
Armour ThyroidTHYROID, PORCINE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-0462
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUS SCROFA THYROID(UNII: 6RV024OAUQ)
(SUS SCROFA THYROID - UNII:6RV024OAUQ) 		SUS SCROFA THYROID180 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE(UNII: 776XM7047L)
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
Product Characteristics
Color brown (light tan) Score no score
Shape ROUND (ROUND) Size 10 mm
Flavor Imprint Code A;TG
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0456-0462-01100 in 1 BOTTLE Type 0: Not a Combination Product04/01/1996
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/01/1996
Armour ThyroidTHYROID, PORCINE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-0463
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUS SCROFA THYROID(UNII: 6RV024OAUQ)
(SUS SCROFA THYROID - UNII:6RV024OAUQ) 		SUS SCROFA THYROID240 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE(UNII: 776XM7047L)
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
Product Characteristics
Color brown (light tan) Score no score
Shape ROUND (ROUND) Size 11 mm
Flavor Imprint Code A;TH
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0456-0463-01100 in 1 BOTTLE Type 0: Not a Combination Product04/01/1996
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/01/1996
Armour ThyroidTHYROID, PORCINE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-0464
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUS SCROFA THYROID(UNII: 6RV024OAUQ)
(SUS SCROFA THYROID - UNII:6RV024OAUQ) 		SUS SCROFA THYROID300 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE(UNII: 776XM7047L)
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
Product Characteristics
Color brown (light tan) Score no score
Shape ROUND (ROUND) Size 13 mm
Flavor Imprint Code A;TI
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0456-0464-01100 in 1 BOTTLE Type 0: Not a Combination Product04/01/1996
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/01/1996

LABELER - Allergan, Inc.(144796497)

PRINCIPAL DISPLAY PANEL

NDC 0456-0457-01

Armour ® Thyroid

(thyroid tablets, USP)

¼ GRAIN (15 mg)

Each tablet contains:

levothyroxine (T4) 9.5 mcg

liothyronine (T3) 2.25 mcg

100 TABLETS

abbvie

Rx only

NDC 0456-0457-01 Armour® Thyroid (thyroid tablets, USP) ¼ GRAIN (15 mg) Each tablet contains: levothyroxine (T4) 9.5 mcg liothyronine (T3) 2.25 mcg 100 TABLETS abbvie Rx only

PRINCIPAL DISPLAY PANEL

NDC 0456-0458-01

Armour ® Thyroid

(thyroid tablets, USP)

½ GRAIN (30 mg)

Each tablet contains:

levothyroxine (T4) 19 mcg

liothyronine (T3) 4.5 mcg

100 TABLETS

abbvie

Rx only

NDC 0456-0458-01 Armour® Thyroid (thyroid tablets, USP) ½ GRAIN (30 mg) Each tablet contains: levothyroxine (T4) 19 mcg liothyronine (T3) 4.5 mcg 100 TABLETS abbvie Rx only

PRINCIPAL DISPLAY PANEL

NDC 0456-0459-01

Armour ® Thyroid

(thyroid tablets, USP)

1 GRAIN (60 mg)

Each tablet contains:

levothyroxine (T4) 38 mcg

liothyronine (T3) 9 mcg

100 TABLETS

abbvie

Rx only

NDC 0456-0459-01 Armour® Thyroid (thyroid tablets, USP) 1 GRAIN (60 mg) Each tablet contains: levothyroxine (T4) 38 mcg liothyronine (T3) 9 mcg 100 TABLETS abbvie Rx only

PRINCIPAL DISPLAY PANEL

NDC 0456-0460-01

Armour ® Thyroid

(thyroid tablets, USP)

1½ GRAIN (90 mg)

Each tablet contains:

levothyroxine (T4) 57 mcg

liothyronine (T3) 13.5 mcg

100 TABLETS

abbvie

Rx only

NDC 0456-0460-01 Armour® Thyroid (thyroid tablets, USP) 1½ GRAIN (90 mg) Each tablet contains: levothyroxine (T4) 57 mcg liothyronine (T3) 13.5 mcg 100 TABLETS abbvie Rx only

PRINCIPAL DISPLAY PANEL

NDC 0456-0461-01

Armour ® Thyroid

(thyroid tablets, USP)

2 GRAIN (120 mg)

Each tablet contains:

levothyroxine (T4) 76 mcg

liothyronine (T3) 18 mcg

100 TABLETS

abbvie

Rx only

NDC 0456-0461-01 Armour® Thyroid (thyroid tablets, USP) 2 GRAIN (120 mg) Each tablet contains: levothyroxine (T4) 76 mcg liothyronine (T3) 18 mcg 100 TABLETS abbvie Rx only

PRINCIPAL DISPLAY PANEL

NDC 0456-0462-01

Armour ® Thyroid

(thyroid tablets, USP)

3 GRAIN (180 mg)

Each tablet contains:

levothyroxine (T4) 114 mcg

liothyronine (T3) 27 mcg

100 TABLETS

abbvie

Rx only

NDC 0456-0462-01 Armour® Thyroid (thyroid tablets, USP) 3 GRAIN (180 mg) Each tablet contains: levothyroxine (T4) 114 mcg liothyronine (T3) 27 mcg 100 TABLETS abbvie Rx only

PRINCIPAL DISPLAY PANEL

NDC 0456-0463-01

Armour ® Thyroid

(thyroid tablets, USP)

4 GRAIN (240 mg)

Each tablet contains:

levothyroxine (T4) 152 mcg

liothyronine (T3) 36 mcg

100 TABLETS

abbvie

Rx only

NDC 0456-0463-01 Armour® Thyroid (thyroid tablets, USP) 4 GRAIN (240 mg) Each tablet contains: levothyroxine (T4) 152 mcg liothyronine (T3) 36 mcg 100 TABLETS abbvie Rx only

PRINCIPAL DISPLAY PANEL

NDC 0456-0464-01

Armour ® Thyroid

(thyroid tablets, USP)

5 GRAIN (300 mg)

Each tablet contains:

levothyroxine (T4) 190 mcg

liothyronine (T3) 45 mcg

100 TABLETS

abbvie

Rx only

NDC 0456-0464-01 Armour® Thyroid (thyroid tablets, USP) 5 GRAIN (300 mg) Each tablet contains: levothyroxine (T4) 190 mcg liothyronine (T3) 45 mcg 100 TABLETS abbvie Rx only

PRINCIPAL DISPLAY PANEL

NDC 0456-1045-01 

Armour ® Thyroid

(thyroid tablets, USP)

1/4 GRAIN ( 15 mg) 

NDC 0456-1045-01 Armour® Thyroid (thyroid tablets, USP) 1/4 GRAIN (15 mg)