NDC Code(s) : 0169-7704-21, 0169-7704-92, 0169-7705-21, 0169-7705-92, 0169-7708-21, 0169-7708-92, 0169-7703-11, 0169-7703-91, 0169-7703-21, 0169-7703-92
Packager : Novo Nordisk

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Norditropinsomatropin INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-7704
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOMATROPIN(UNII: NQX9KB6PCL)
(SOMATROPIN - UNII:NQX9KB6PCL) 		SOMATROPIN5 mg in 1.5 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE(UNII: 4QD397987E)1 mg in 1.5 mL
HYDROCHLORIC ACID(UNII: QTT17582CB)
MANNITOL(UNII: 3OWL53L36A)60 mg in 1.5 mL
PHENOL(UNII: 339NCG44TV)4.5 mg in 1.5 mL
POLOXAMER 188(UNII: LQA7B6G8JG)4.5 mg in 1.5 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-7704-211 in 1 CARTON 03/01/2010
11.5 mL in 1 SYRINGE, PLASTIC Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:0169-7704-921 in 1 CARTON 03/01/2010
21.5 mL in 1 SYRINGE, PLASTIC 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 BLA021148 01/03/2005
Norditropinsomatropin INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-7705
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOMATROPIN(UNII: NQX9KB6PCL)
(SOMATROPIN - UNII:NQX9KB6PCL) 		SOMATROPIN10 mg in 1.5 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE(UNII: 4QD397987E)1 mg in 1.5 mL
HYDROCHLORIC ACID(UNII: QTT17582CB)
MANNITOL(UNII: 3OWL53L36A)60 mg in 1.5 mL
PHENOL(UNII: 339NCG44TV)4.5 mg in 1.5 mL
POLOXAMER 188(UNII: LQA7B6G8JG)4.5 mg in 1.5 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-7705-211 in 1 CARTON 03/01/2010
11.5 mL in 1 SYRINGE, PLASTIC Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:0169-7705-921 in 1 CARTON 03/01/2010
21.5 mL in 1 SYRINGE, PLASTIC 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 BLA021148 01/02/2006
Norditropinsomatropin INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-7708
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOMATROPIN(UNII: NQX9KB6PCL)
(SOMATROPIN - UNII:NQX9KB6PCL) 		SOMATROPIN15 mg in 1.5 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE(UNII: 4QD397987E)1.7 mg in 1.5 mL
HYDROCHLORIC ACID(UNII: QTT17582CB)
MANNITOL(UNII: 3OWL53L36A)58 mg in 1.5 mL
PHENOL(UNII: 339NCG44TV)4.5 mg in 1.5 mL
POLOXAMER 188(UNII: LQA7B6G8JG)4.5 mg in 1.5 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-7708-211 in 1 CARTON 03/01/2010
11.5 mL in 1 SYRINGE, PLASTIC Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:0169-7708-921 in 1 CARTON 03/01/2010
21.5 mL in 1 SYRINGE, PLASTIC 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 BLA021148 01/03/2005
Norditropinsomatropin INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-7703
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOMATROPIN(UNII: NQX9KB6PCL)
(SOMATROPIN - UNII:NQX9KB6PCL) 		SOMATROPIN30 mg in 3 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE(UNII: 4QD397987E)3.3 mg in 3 mL
POLOXAMER 188(UNII: LQA7B6G8JG)9 mg in 3 mL
PHENOL(UNII: 339NCG44TV)9 mg in 3 mL
MANNITOL(UNII: 3OWL53L36A)117 mg in 3 mL
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-7703-111 in 1 CARTON 23/01/2015
13 mL in 1 SYRINGE Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:0169-7703-911 in 1 CARTON 23/01/2015
23 mL in 1 SYRINGE Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
3NDC:0169-7703-211 in 1 CARTON 23/01/2015
33 mL in 1 SYRINGE Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
4NDC:0169-7703-921 in 1 CARTON 23/01/2015
43 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 BLA021148 03/30/2009

LABELER - Novo Nordisk(622920320)

Establishment
Name Address ID/FEI Business Operations
Novo Nordisk A/S - Hax 306711800 MANUFACTURE(0169-7704, 0169-7705, 0169-7708, 0169-7703), API MANUFACTURE(0169-7704, 0169-7705, 0169-7708, 0169-7703)

Establishment
Name Address ID/FEI Business Operations
Novo Nordisk A/S - Kv 311359009 MANUFACTURE(0169-7704, 0169-7705, 0169-7708, 0169-7703)

PRINCIPAL DISPLAY PANEL

Norditropin®  FlexPro®

(somatropin) injection

5 mg/1.5 mL Prefilled Pen

1 x 1.5 mL prefilled pen

Each 1.5 mL contains 5 mg somatropin

CONTAINS ONE

NORDITROPIN® FlexPro® 5 mg/1.5 mL

Single patient use only

Rx only

NDC 0169-7704-21

List: 770421

5 mg Trade Carton

PRINCIPAL DISPLAY PANEL

Norditropin®  FlexPro®

(somatropin) injection

10 mg/1.5 mL Prefilled Pen

1 x 1.5 mL prefilled disposable pen

Each 1.5 mL contains 10 mg somatropin

CONTAINS ONE

NORDITROPIN® FlexPro® 10 mg/1.5 mL

Single patient use only

Rx only

NDC 0169-7705-21

List: 770521

10 mg Trade Carton

PRINCIPAL DISPLAY PANEL

Norditropin®  FlexPro®

(somatropin) injection

15 mg/1.5 mL Prefilled Pen

1 x 1.5 mL prefilled disposable pen

Each 1.5 mL contains 15 mg somatropin

CONTAINS ONE

NORDITROPIN® FlexPro® 15 mg/1.5 mL

Single patient use only

Rx only

NDC 0169-7708-21

List: 770821

15 mg Trade Carton

PRINCIPAL DISPLAY PANEL

Norditropin® FlexPro®

(somatropin) injection

30 mg / 3 mLPrefilled Pen

1x3 mL prefilled pen

Each 3 mL contains: 30 mg somatropin

CONTAINS ONE NORDITROPIN® FlexPro® 30 mg / 3 mL

Single patient use only

Rx only

NDC 0169-7703-21

List: 770321

30 mg Trade Carton