NDC Code(s) : 61314-454-20, 61314-454-36, 61314-454-68, 61314-473-64, 61314-473-20, 61314-476-64, 61314-509-64, 61314-517-36, 61314-531-64
Packager : Sandoz Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

HYRIMOZadalimumab-adaz INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61314-454
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ADALIMUMAB(UNII: FYS6T7F842)
(ADALIMUMAB - UNII:FYS6T7F842) 		ADALIMUMAB80 mg in 0.8 mL
Inactive Ingredients
Ingredient Name Strength
ADIPIC ACID(UNII: 76A0JE0FKJ)1.75 mg in 0.8 mL
MANNITOL(UNII: 3OWL53L36A)33.6 mg in 0.8 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.32 mg in 0.8 mL
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61314-454-202 in 1 CARTON 07/01/2023
10.8 mL in 1 SYRINGE Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:61314-454-363 in 1 CARTON 07/01/2023
20.8 mL in 1 SYRINGE Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
3NDC:61314-454-683 in 1 CARTON 07/01/2023
30.8 mL in 1 SYRINGE, GLASS 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 BLA761071 07/01/2023
HYRIMOZadalimumab-adaz INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61314-473
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ADALIMUMAB(UNII: FYS6T7F842)
(ADALIMUMAB - UNII:FYS6T7F842) 		ADALIMUMAB40 mg in 0.4 mL
Inactive Ingredients
Ingredient Name Strength
ADIPIC ACID(UNII: 76A0JE0FKJ)0.88 mg in 0.4 mL
MANNITOL(UNII: 3OWL53L36A)16.8 mg in 0.4 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.16 mg in 0.4 mL
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61314-473-642 in 1 CARTON 07/01/2023
10.4 mL in 1 SYRINGE, GLASS Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:61314-473-202 in 1 CARTON 07/01/2023
20.4 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 BLA761071 07/01/2023
HYRIMOZadalimumab-adaz INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61314-476
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ADALIMUMAB(UNII: FYS6T7F842)
(ADALIMUMAB - UNII:FYS6T7F842) 		ADALIMUMAB20 mg in 0.2 mL
Inactive Ingredients
Ingredient Name Strength
ADIPIC ACID(UNII: 76A0JE0FKJ)0.44 mg in 0.2 mL
MANNITOL(UNII: 3OWL53L36A)8.4 mg in 0.2 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.08 mg in 0.2 mL
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61314-476-642 in 1 CARTON 07/01/2023
10.2 mL in 1 SYRINGE, GLASS 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 BLA761071 07/01/2023
HYRIMOZadalimumab-adaz INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61314-509
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ADALIMUMAB(UNII: FYS6T7F842)
(ADALIMUMAB - UNII:FYS6T7F842) 		ADALIMUMAB10 mg in 0.1 mL
Inactive Ingredients
Ingredient Name Strength
ADIPIC ACID(UNII: 76A0JE0FKJ)0.22 mg in 0.1 mL
MANNITOL(UNII: 3OWL53L36A)4.2 mg in 0.1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.04 mg in 0.1 mL
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61314-509-641 in 1 CARTON 07/01/2023
10.1 mL in 1 SYRINGE, GLASS 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 BLA761071 07/01/2023
HYRIMOZadalimumab-adaz KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61314-517
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ADIPIC ACID(UNII: 76A0JE0FKJ)1.75 mg in 0.8 mL
MANNITOL(UNII: 3OWL53L36A)33.6 mg in 0.8 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.32 mg in 0.8 mL
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
ADIPIC ACID(UNII: 76A0JE0FKJ)0.88 mg in 0.4 mL
MANNITOL(UNII: 3OWL53L36A)16.8 mg in 0.4 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.16 mg in 0.4 mL
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61314-517-363 in 1 CARTON 07/01/2023
11 in 1 KIT 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 BLA761071 07/01/2023
HYRIMOZadalimumab-adaz KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61314-531
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ADIPIC ACID(UNII: 76A0JE0FKJ)1.75 mg in 0.8 mL
MANNITOL(UNII: 3OWL53L36A)33.6 mg in 0.8 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.32 mg in 0.8 mL
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
ADIPIC ACID(UNII: 76A0JE0FKJ)0.88 mg in 0.4 mL
MANNITOL(UNII: 3OWL53L36A)16.8 mg in 0.4 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.16 mg in 0.4 mL
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61314-531-642 in 1 CARTON 07/01/2023
11 in 1 KIT 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 BLA761071 07/01/2023

LABELER - Sandoz Inc(005387188)

PRINCIPAL DISPLAY PANEL

NDC 61314-876-02

Rx only

Hyrimoz®

(adalimumab-adaz)

Injection

40 mg/0.8 mL

For Subcutaneous Use Only

2 Single-Dose Prefilled Syringes

with needle guard

40-08 PFS label

PRINCIPAL DISPLAY PANEL

NDC 61314-871-02

Rx only

Hyrimoz®

(adalimumab-adaz)

Injection

40 mg/0.8 mL

For Subcutaneous Use Only

2 Single-Dose Prefilled Sensoready ® Pens

40-08 Pen label

PRINCIPAL DISPLAY PANEL

NDC 61314-741-01

Hyrimoz®

(adalimumab-adaz)

Injection

10 mg/0.2 mL

Rx Only

For Subcutaneous Use Only

1Single-Dose Prefilled Syringe

10-02-label

PRINCIPAL DISPLAY PANEL

NDC 61314-509-64

Rx Only

Hyrimoz®

(adalimumab-adaz)

Injection

10 mg/0.1 mL

Rx Only

For Subcutaneous Use Only

2Single-Dose Prefilled Syringes

10-01 PFS Label

PRINCIPAL DISPLAY PANEL

NDC 61314-476-64

Rx Only

Hyrimoz®

(adalimumab-adaz)

Injection

20 mg/0.2 mL

For Subcutaneous Use Only

2Single-Dose Prefilled Syringes

20-02 PFS label

PRINCIPAL DISPLAY PANEL

NDC 61314-850-02

Rx Only

Hyrimoz®

(adalimumab-adaz)

Injection

20 mg/0.4 mL

For Subcutaneous Use Only

2Single-Dose Prefilled Syringes with needle guard

20-04 PFS label

PRINCIPAL DISPLAY PANEL

NDC 61314-473-20

Rx Only

Hyrimoz®

(adalimumab-adaz)

Injection

40 mg/0.4 mL

For Subcutaneous Use Only

2Single-Dose Prefilled Sensoready® Pens

40-04 PEN label

PRINCIPAL DISPLAY PANEL

NDC 61314-454-36

Rx Only

CROHN’S DISEASE AND ULCERATIVE COLITIS STARTER PACK

Hyrimoz®

(adalimumab-adaz)

Injection

THREE 80 mg/0.8 mL

3Single-Dose Prefilled Sensoready® Pens

For Subcutaneous Use Only

Each patient is required to receive the enclosed Medication Guide.

Sterile solution. Contains no preservatives.

Prefilled Syringe and injection device are not made with natural rubber latex.

Starter Package contains:

3 packs each containing 1 Single-Dose Prefilled Sensoready ® Pen with 29 gauge ½ inch needle

Each dose pack contains:

1 Single-Dose Prefilled Sensoready ® Pen,

1 Prescribing Information,

1 Medication Guide/Instructions for Use, and

1 Quick Reference Guide.

ATTENTION: Dispense the enclosed Medication Guide to each patient.

80-08 PEN label

PRINCIPAL DISPLAY PANEL

NDC 61314-517-36

Rx Only

PLAQUE PSORIASIS STARTER PACK

Hyrimoz®

(adalimumab-adaz)

Injection

ONE 80 mg/0.8 mL

TWO 40 mg/0.4 mL

For Subcutaneous Use Only

3Single-Dose Prefilled Sensoready® Pens

Each patient is required to receive the enclosed Medication Guide.

Sterile solution. Contains no preservatives.

Prefilled Syringe and injection device are not made with natural rubber latex.

Starter Package contains:

3 packs each containing 1 Single-Dose Prefilled Sensoready ® Pen with 29 gauge ½ inch needle

Each dose pack contains:

1 Single-Dose Prefilled Sensoready ® Pen,

1 Prescribing Information,

1 Medication Guide/Instructions for Use, and

1 Quick Reference Guide.

ATTENTION: Dispense the enclosed Medication Guide to each patient.

80-40 3Pen label

PRINCIPAL DISPLAY PANEL

NDC 61314-454-68

Rx Only

PEDIATRIC CROHN’S DISEASE STARTER PACK

FOR PEDIATRIC PATIENTS ≥40 kg

Hyrimoz®

(adalimumab-adaz)

Injection

THREE 80 mg/0.8 mL

3Single-Dose Prefilled Syringes with needle guard

For Subcutaneous Use Only

Each patient is required to receive the enclosed Medication Guide.

Sterile solution. Contains no preservatives.

Prefilled Syringe and injection device are not made with natural rubber latex.

Starter Package contains:

3 packs each containing 1 Single-Dose Prefilled Syringe with 29 gauge ½ inch needle and needle guard

Each dose pack contains:

1 Single-Dose Prefilled Syringe,

1 Prescribing Information,

1 Medication Guide/Instructions for Use, and

1 Quick Reference Guide.

ATTENTION: Dispense the enclosed Medication Guide to each patient.

80-08 3PFS label

PRINCIPAL DISPLAY PANEL

NDC 61314-531-64

Rx Only

PEDIATRIC CROHN’S DISEASE STARTER PACK

FOR PEDIATRIC PATIENTS <40 kg

Hyrimoz®

(adalimumab-adaz)

Injection

ONE 80 mg/0.8 mL

ONE 40 mg/0.4 mL

2Single-Dose Prefilled Syringes with needle guard

For Subcutaneous Use Only

Each patient is required to receive the enclosed Medication Guide.

Sterile solution. Contains no preservatives.

Prefilled Syringe and injection device are not made with natural rubber latex.

Starter Package contains:

2 packs each containing 1 Single-Dose Prefilled Syringe with 29 gauge ½ inch needle and needle guard

Each dose pack contains:

1 Single-Dose Prefilled Syringe,

1 Prescribing Information,

1 Medication Guide/Instructions for Use, and

1 Quick Reference Guide.

ATTENTION: Dispense the enclosed Medication Guide to each patient.

80-40 2PFS label