NDC Code(s) : 59627-333-04, 59627-222-05, 59627-003-01, 59627-002-07, 59627-002-06
Packager : Biogen Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AVONEXinterferon beta-1a KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59627-333
Route of Administration INTRAMUSCULAR DEA Schedule
Inactive Ingredients
Ingredient Name Strength
Sodium acetate(UNII: 4550K0SC9B)0.79 mg in 0.5 mL
Arginine hydrochloride(UNII: F7LTH1E20Y)15.8 mg in 0.5 mL
Acetic Acid(UNII: Q40Q9N063P)0.25 mg in 0.5 mL
Polysorbate 20(UNII: 7T1F30V5YH)0.025 mg in 0.5 mL
Water(UNII: 059QF0KO0R)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59627-333-041 in 1 CARTON Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)29/08/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103628 08/29/2014
AVONEXinterferon beta-1a KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59627-222
Route of Administration INTRAMUSCULAR DEA Schedule
Inactive Ingredients
Ingredient Name Strength
Sodium acetate(UNII: 4550K0SC9B)0.79 mg in 0.5 mL
Arginine hydrochloride(UNII: F7LTH1E20Y)15.8 mg in 0.5 mL
Acetic Acid(UNII: Q40Q9N063P)0.25 mg in 0.5 mL
Polysorbate 20(UNII: 7T1F30V5YH)0.025 mg in 0.5 mL
Water(UNII: 059QF0KO0R)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59627-222-051 in 1 CARTON Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)29/08/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103628 08/29/2014
Avonex PenInterferon Beta-1a INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59627-003
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
interferon beta-1a(UNII: XRO4566Q4R)
(interferon beta-1a - UNII:XRO4566Q4R) 		interferon beta-1a30 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
Sodium acetate(UNII: 4550K0SC9B)0.79 mg in 0.5 mL
Arginine Hydrochloride(UNII: F7LTH1E20Y)15.8 mg in 0.5 mL
Acetic Acid(UNII: Q40Q9N063P)0.25 mg in 0.5 mL
Polysorbate 20(UNII: 7T1F30V5YH)0.025 mg in 0.5 mL
Water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59627-003-011 in 1 CARTON 23/05/2003
10.5 mL in 1 SYRINGE Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103628 05/23/2003
AvonexInterferon Beta-1a INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59627-002
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
interferon beta-1a(UNII: XRO4566Q4R)
(interferon beta-1a - UNII:XRO4566Q4R) 		interferon beta-1a30 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
Sodium acetate(UNII: 4550K0SC9B)0.79 mg in 0.5 mL
Arginine Hydrochloride(UNII: F7LTH1E20Y)15.8 mg in 0.5 mL
Acetic Acid(UNII: Q40Q9N063P)0.25 mg in 0.5 mL
Polysorbate 20(UNII: 7T1F30V5YH)0.025 mg in 0.5 mL
Water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59627-002-061 in 1 CARTON 23/05/2003
1NDC:59627-002-071 in 1 TRAY
10.5 mL in 1 SYRINGE Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103628 05/23/2003

LABELER - Biogen Inc.(009492211)

Establishment
Name Address ID/FEI Business Operations
Packaging Coordinators, LLC 078525133 LABEL(59627-003, 59627-002, 59627-333, 59627-222), PACK(59627-003, 59627-002, 59627-333, 59627-222)

PRINCIPAL DISPLAY PANEL

Principal Display Panel - 30 mcg Carton Label

NDC 59627-003-01

Avonex Pen ®

(interferon beta-1a)

Injection

30 mcg/0.5 mL Single-Use Prefilled Autoinjector

For Intramuscular Injection

Once a Week

Avonex Pen® Administration Dose Pack

ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.

Store refrigerated at 2-8°C (36-46°F).

Do not freeze or expose to high temperatures. Protect from light.

The recommended dosage of Avonex® is 30 mcg injected intramuscularly
once weekly. See package insert for full prescribing information.

This Product Contains Dry Natural Rubber.

Rx only

Principal Display Panel - 30 mcg Carton Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel - 30 mcg Carton Label

NDC 59627-002-06

Avonex ®
(interferon beta-1a)
Injection

30 mcg/0.5 mL Single-Use Prefilled Syringe

For Intramuscular Injection

Once a Week

Avonex ® Administration Dose Pack

ATTENTION PHARMACIST: Each patient is required
to receive the enclosed Medication Guide.

Store refrigerated at 2-8°C (36-46°F)

Do not freeze or expose to high temperatures.

Protect from light.

See package insert for dosage and administration.

This Product Contains Dry Natural Rubber.

Rx only

Principal Display Panel - 30 mcg Carton Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Carton Label

NDC 59627-333-04

Avonex Pen ®
(interferon beta-1a)
Injection

30 mcg/0.5 mL Single-Use Prefilled Autoinjector

For Intramuscular Injection

Once a Week

Contents:

4 Avonex Pen ® Administration Dose Packs

Store refrigerated at 2-8°C (36-46°F)

Do not freeze or expose to high temperatures. Protect from light.

The recommended dosage of Avonex ® is 30 mcg injected intramuscularly
once weekly. See package insert for full prescribing information.

ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.

Principal Display Panel - Carton Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Carton Label

NDC 59627-222-05

Avonex ®
(interferon beta-1a)
Injection

30 mcg/0.5 mL Single-Use Prefilled Syringe

For Intramuscular Injection

Once a Week

Contents:

4 Avonex ® Administration Dose Packs

ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.

This Product Contains Dry Natural Rubber.

Rx only

Store refrigerated at 2-8°C (36-46°F).

Do not freeze or expose to high temperatures.

Protect from light.

See package insert for dosage and administration.

Principal Display Panel - Carton Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Tray Lid Label

Avonex ® (interferon beta-1a)

30 mcg/0.5 mL Single-Use Prefilled Syringe

For Intramuscular Injection

Store refrigerated at 2-8°C (36-46°F). Do not freeze or expose to high temperatures.

Protect from light. Contents: 1 single-use prefilled syringe of Avonex® and 1, 23G, 1 1/4" needle. See package insert for dosage and administration. This Product Contains Dry Natural Rubber. ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide. U.S. License# 1697

Biogen Inc., Cambridge, MA 02142 1-800-456-2255 Rx only 46043 -02

NDC 59627-002-07

Principal Display Panel - Tray Lid Label