ENJUVIA (Page 8 of 8)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL — 0.3 mg

Enjuvia 0.3 mg Label
(click image for full-size original)

0.3 mg

Enjuvia®

(synthetic conjugated estrogens, B) Tablets

PHARMACIST: Dispense the Package Insert provided separately to each patient.

Rx only

Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL — 0.625 mg

Enjuvia 0.625 mg Label
(click image for full-size original)

0.625 mg

Enjuvia®

(synthetic conjugated estrogens, B) Tablets

PHARMACIST: Dispense the Package Insert provided separately to each patient.

Rx only

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL — 0.9 mg

Enjuvia 0.9 mg Label
(click image for full-size original)

0.9 mg

Enjuvia®

(synthetic conjugated estrogens, B) Tablets

PHARMACIST: Dispense the Package Insert provided separately to each patient.

Rx only

ENJUVIA synthetic conjugated estrogens, b tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6165(NDC:51285-409)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTROGENS, CONJUGATED SYNTHETIC B (ESTROGENS, CONJUGATED SYNTHETIC B) ESTROGENS, CONJUGATED SYNTHETIC B 0.9 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBYL PALMITATE
BUTYLATED HYDROXYANISOLE
SILICON DIOXIDE
D&C YELLOW NO. 10
EDETATE DISODIUM
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
GLYCERIN
HYPROMELLOSE
FERRIC OXIDE RED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
ETHYLCELLULOSE
POLYETHYLENE GLYCOL
POLYSORBATE 80
WATER
TITANIUM DIOXIDE
TRIETHYL CITRATE
TRIACETIN
Product Characteristics
Color turquoise Score no score
Shape OVAL Size 10mm
Flavor Imprint Code E;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6165-0 10 TABLET (TABLET) in 1 BOTTLE None
2 NDC:54868-6165-1 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021443 09/03/2010
ENJUVIA synthetic conjugated estrogens, b tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6163(NDC:51285-408)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTROGENS, CONJUGATED SYNTHETIC B (ESTROGENS, CONJUGATED SYNTHETIC B) ESTROGENS, CONJUGATED SYNTHETIC B 0.625 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBYL PALMITATE
BUTYLATED HYDROXYANISOLE
SILICON DIOXIDE
EDETATE DISODIUM
GLYCERIN
HYPROMELLOSE
FERRIC OXIDE RED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
ETHYLCELLULOSE
POLYETHYLENE GLYCOL
POLYSORBATE 80
WATER
TITANIUM DIOXIDE
TRIETHYL CITRATE
TRIACETIN
Product Characteristics
Color pink Score no score
Shape OVAL Size 10mm
Flavor Imprint Code E;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6163-0 10 TABLET (TABLET) in 1 BOTTLE None
2 NDC:54868-6163-1 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021443 09/03/2010
ENJUVIA synthetic conjugated estrogens, b tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6164(NDC:51285-406)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTROGENS, CONJUGATED SYNTHETIC B (ESTROGENS, CONJUGATED SYNTHETIC B) ESTROGENS, CONJUGATED SYNTHETIC B 0.3 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBYL PALMITATE
BUTYLATED HYDROXYANISOLE
SILICON DIOXIDE
EDETATE DISODIUM
GLYCERIN
HYPROMELLOSE
FERRIC OXIDE RED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
ETHYLCELLULOSE
POLYETHYLENE GLYCOL
POLYSORBATE 80
WATER
TITANIUM DIOXIDE
TRIETHYL CITRATE
TRIACETIN
Product Characteristics
Color white Score no score
Shape OVAL Size 8mm
Flavor Imprint Code E;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6164-0 10 TABLET (TABLET) in 1 BOTTLE None
2 NDC:54868-6164-1 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021443 09/03/2010
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 03/2010 Physicians Total Care, Inc.

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