Envarsus XR (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — Envarsus 0.75 mg 30 Count Carton Label

NDC 68992-3075-3

Envarsus XR®

(tacrolimus
extended-release tablets)

0.75 mg

ONCE-DAILY

Swallow tablet whole.

Do not chew, divide,
or crush tablet.

Dosage: See Package Insert
for dosage information.

Always dispense with a Medication Guide

For oral use only

Veloxis PHARMACEUTICALS

30 Tablets

Envarsus 0.75mg 30 count Carton Label
(click image for full-size original)


PRINCIPAL DISPLAY PANEL — Envarsus 0.75 mg 30 Count Bottle Label

NDC 68992-3075-3

Envarsus XR®

(tacrolimus extended-release tablets)

0.75 mg

ONCE-DAILY

Always Dispense With a Medication Guide

Swallow tablet whole.

Do not chew, divide, or crush tablet.

30 Tablets Rx only

Veloxis PHARMACEUTICALS

Envarsus 0.75mg 30 count bottle Label
(click image for full-size original)


PRINCIPAL DISPLAY PANEL — Envarsus 0.75 mg 100 Count Carton Label

NDC 68992-3075-1

Envarsus XR®

(tacrolimus
extended-release tablets)

0.75 mg

ONCE-DAILY

Swallow tablet whole.

Do not chew, divide,
or crush tablet.

Dosage: See Package Insert
for dosage information.

Always dispense with a Medication Guide

For oral use only

Veloxis PHARMACEUTICALS

100 Tablets

Envarsus 0.75mg 100 count Carton Carton
(click image for full-size original)


PRINCIPAL DISPLAY PANEL — Envarsus 0.75 mg 100 Count Bottle Label

NDC 68992-3075-1

Envarsus XR®

(tacrolimus extended-release tablets)

0.75 mg

ONCE-DAILY

Always Dispense With a Medication Guide

Swallow tablet whole.

Do not chew, divide, or crush tablet.

100 Tablets Rx only

Veloxis PHARMACEUTICALS

Envarsus 0.75mg 100 count bottle Label
(click image for full-size original)


PRINCIPAL DISPLAY PANEL — Envarsus 1 mg 30 Count Carton Label

NDC 68992-3010-3

Envarsus XR®

(tacrolimus
extended-release tablets)

1 mg

ONCE-DAILY

Swallow tablet whole.

Do not chew, divide,
or crush tablet.

Dosage: See Package Insert
for dosage information.

Always dispense with a Medication Guide

For oral use only

Veloxis PHARMACEUTICALS

30 Tablets

Envarsus 1mg 30 count carton label
(click image for full-size original)


PRINCIPAL DISPLAY PANEL — Envarsus 1 mg 30 Count Bottle Label

NDC 68992-3010-3

Envarsus XR®

(tacrolimus extended-release tablets)

1 mg

ONCE-DAILY

Always Dispense With a Medication Guide

Swallow tablet whole.

Do not chew, divide, or crush tablet.

30 Tablets Rx only

Veloxis PHARMACEUTICALS

Envarsus 1mg 30 count bottle Label
(click image for full-size original)


PRINCIPAL DISPLAY PANEL — Envarsus 1 mg 100 Count Carton Label

NDC 68992-3010-1

Envarsus XR®

(tacrolimus
extended-release tablets)

1 mg

ONCE-DAILY

Swallow tablet whole.

Do not chew, divide,
or crush tablet.

Dosage: See Package Insert
for dosage information.

Always dispense with a Medication Guide

For oral use only

Veloxis PHARMACEUTICALS

100 Tablets

Envarsus 1mg 100 count carton label
(click image for full-size original)


PRINCIPAL DISPLAY PANEL — Envarsus 1 mg 100 Count Bottle Label

NDC 68992-3010-1

Envarsus XR®

(tacrolimus extended-release tablets)

1 mg

ONCE-DAILY

Always Dispense With a Medication Guide

Swallow tablet whole.

Do not chew, divide, or crush tablet.

100 Tablets Rx only

Veloxis PHARMACEUTICALS

Envarsus 1mg 100 count bottle Label
(click image for full-size original)


PRINCIPAL DISPLAY PANEL — Envarsus 4 mg 30 Count Carton Label

NDC 68992-3040-3

Envarsus XR®

(tacrolimus
extended-release tablets)

4 mg

ONCE-DAILY

Swallow tablet whole.

Do not chew, divide,
or crush tablet.

Dosage: See Package Insert
for dosage information.

Always dispense with a Medication Guide

For oral use only

Veloxis PHARMACEUTICALS

30 Tablets

Envarsus 4mg 30 count Carton label
(click image for full-size original)


PRINCIPAL DISPLAY PANEL — Envarsus 4 mg 30 Count Bottle Label

NDC 68992-3040-3

Envarsus XR®

(tacrolimus extended-release tablets)

4 mg

ONCE-DAILY

Always Dispense With a Medication Guide

Swallow tablet whole.

Do not chew, divide, or crush tablet.

30 Tablets Rx only

Veloxis PHARMACEUTICALS

Envarsus 4mg 30 count bottle label
(click image for full-size original)


PRINCIPAL DISPLAY PANEL — Envarsus 4 mg 100 Count Carton Label

NDC 68992-3040-1

Envarsus XR®

(tacrolimus
extended-release tablets)

4 mg

ONCE-DAILY

Swallow tablet whole.

Do not chew, divide,
or crush tablet.

Dosage: See Package Insert
for dosage information.

Always dispense with a Medication Guide

For oral use only

Veloxis PHARMACEUTICALS

100 Tablets

Envarsus 4mg 100 count Carton label
(click image for full-size original)


PRINCIPAL DISPLAY PANEL — Envarsus 4 mg 100 Count Bottle Label

NDC 68992-3040-1

Envarsus XR®

(tacrolimus extended-release tablets)

4 mg

ONCE-DAILY

Always Dispense With a Medication Guide

Swallow tablet whole.

Do not chew, divide, or crush tablet.

100 Tablets

Veloxis PHARMACEUTICALS

Envarsus 4mg 100 count bottle Label
(click image for full-size original)
ENVARSUS XR tacrolimus tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68992-3075
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TACROLIMUS (TACROLIMUS ANHYDROUS) TACROLIMUS ANHYDROUS 0.75 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL 6000
POLOXAMER 188
MAGNESIUM STEARATE
TARTARIC ACID
BUTYLATED HYDROXYTOLUENE
DIMETHICONE
Product Characteristics
Color WHITE (White to Off-White) Score no score
Shape OVAL Size 11mm
Flavor Imprint Code 075;TCS
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68992-3075-3 1 POUCH in 1 CARTON contains a POUCH
1 1 BOTTLE, PLASTIC in 1 POUCH This package is contained within the CARTON (68992-3075-3) and contains a BOTTLE, PLASTIC
1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC This package is contained within a POUCH and a CARTON (68992-3075-3)
2 NDC:68992-3075-1 1 POUCH in 1 CARTON contains a POUCH
2 1 BOTTLE in 1 POUCH This package is contained within the CARTON (68992-3075-1) and contains a BOTTLE
2 100 TABLET, EXTENDED RELEASE in 1 BOTTLE This package is contained within a POUCH and a CARTON (68992-3075-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206406 09/01/2015
ENVARSUS XR tacrolimus tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68992-3010
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TACROLIMUS (TACROLIMUS ANHYDROUS) TACROLIMUS ANHYDROUS 1 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL 6000
POLOXAMER 188
MAGNESIUM STEARATE
TARTARIC ACID
BUTYLATED HYDROXYTOLUENE
DIMETHICONE
Product Characteristics
Color WHITE (White to Off-White) Score no score
Shape OVAL Size 11mm
Flavor Imprint Code 1;TCS
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68992-3010-3 1 POUCH in 1 CARTON contains a POUCH
1 1 BOTTLE, PLASTIC in 1 POUCH This package is contained within the CARTON (68992-3010-3) and contains a BOTTLE, PLASTIC
1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC This package is contained within a POUCH and a CARTON (68992-3010-3)
2 NDC:68992-3010-1 1 POUCH in 1 CARTON contains a POUCH
2 1 BOTTLE in 1 POUCH This package is contained within the CARTON (68992-3010-1) and contains a BOTTLE
2 100 TABLET, EXTENDED RELEASE in 1 BOTTLE This package is contained within a POUCH and a CARTON (68992-3010-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206406 09/01/2015
ENVARSUS XR tacrolimus tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68992-3040
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TACROLIMUS (TACROLIMUS ANHYDROUS) TACROLIMUS ANHYDROUS 4 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL 6000
POLOXAMER 188
MAGNESIUM STEARATE
TARTARIC ACID
BUTYLATED HYDROXYTOLUENE
DIMETHICONE
Product Characteristics
Color WHITE (White to Off-White) Score no score
Shape OVAL Size 16mm
Flavor Imprint Code 4;TCS
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68992-3040-3 1 POUCH in 1 CARTON contains a POUCH
1 1 BOTTLE, PLASTIC in 1 POUCH This package is contained within the CARTON (68992-3040-3) and contains a BOTTLE, PLASTIC
1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC This package is contained within a POUCH and a CARTON (68992-3040-3)
2 NDC:68992-3040-1 1 POUCH in 1 CARTON contains a POUCH
2 1 BOTTLE in 1 POUCH This package is contained within the CARTON (68992-3040-1) and contains a BOTTLE
2 100 TABLET, EXTENDED RELEASE in 1 BOTTLE This package is contained within a POUCH and a CARTON (68992-3040-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206406 09/01/2015
Labeler — Veloxis Pharmaceuticals, Inc (028252150)
Establishment
Name Address ID/FEI Operations
Veloxis Pharmaceuticals, Inc 028252150 MANUFACTURE (68992-3075), MANUFACTURE (68992-3010), MANUFACTURE (68992-3040)
Establishment
Name Address ID/FEI Operations
Rottendorf Pharma GmbH 315974691 manufacture (68992-3075), manufacture (68992-3010), manufacture (68992-3040), analysis (68992-3075), analysis (68992-3010), analysis (68992-3040), label (68992-3075), label (68992-3010), label (68992-3040), pack (68992-3075), pack (68992-3010), pack (68992-3040)
Establishment
Name Address ID/FEI Operations
Carton Service, Incorporated 928861723 label (68992-3075), label (68992-3010), label (68992-3040), pack (68992-3075), pack (68992-3010), pack (68992-3040)

Revised: 09/2021 Veloxis Pharmaceuticals, Inc

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