NDC Code(s) : 0169-3687-12, 0169-3687-92, 0169-6438-10, 0169-6438-90, 0169-6438-97, 0169-6438-98, 0169-6432-55, 0169-6432-10
Packager : Novo Nordisk

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Levemirinsulin detemir INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-3687
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN DETEMIR(UNII: 4FT78T86XV)
(INSULIN DETEMIR - UNII:4FT78T86XV) 		INSULIN DETEMIR100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(UNII: GR686LBA74)
GLYCERIN(UNII: PDC6A3C0OX)
METACRESOL(UNII: GGO4Y809LO)
PHENOL(UNII: 339NCG44TV)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ZINC(UNII: J41CSQ7QDS)
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-3687-121 in 1 CARTON 27/03/2006
110 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
2NDC:0169-3687-921 in 1 CARTON 27/03/2006
210 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA021536 03/27/2006
Levemirinsulin detemir INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-6438
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN DETEMIR(UNII: 4FT78T86XV)
(INSULIN DETEMIR - UNII:4FT78T86XV) 		INSULIN DETEMIR100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(UNII: GR686LBA74)
GLYCERIN(UNII: PDC6A3C0OX)
METACRESOL(UNII: GGO4Y809LO)
PHENOL(UNII: 339NCG44TV)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ZINC(UNII: J41CSQ7QDS)
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-6438-105 in 1 CARTON 31/10/2013
13 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0169-6438-971 in 1 CARTON 31/10/2013
2NDC:0169-6438-903 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:0169-6438-981 in 1 CARTON 31/10/2013
3NDC:0169-6438-903 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA021536 10/31/2013
Levemirinsulin detemir INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-6432
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN DETEMIR(UNII: 4FT78T86XV)
(INSULIN DETEMIR - UNII:4FT78T86XV) 		INSULIN DETEMIR100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(UNII: GR686LBA74)
GLYCERIN(UNII: PDC6A3C0OX)
METACRESOL(UNII: GGO4Y809LO)
PHENOL(UNII: 339NCG44TV)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ZINC(UNII: J41CSQ7QDS)
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-6432-105 in 1 CARTON 12/02/2022
1NDC:0169-6432-553 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA021536 10/31/2013

LABELER - Novo Nordisk(622920320)

PRINCIPAL DISPLAY PANEL

Levemir®

(insulin detemir) injection

NDC 0169-3687-12

List 368712

100 units/mL (U-100)

For subcutaneous use only

Rx Only

Use only with a U-100 syringe.

10 mL Multiple-dose Vial

novo nordisk®

Image of Levemir vial carton

PRINCIPAL DISPLAY PANEL

NDC 0169-6438-10 List 643810

Levemir® FlexTouch®

(insulin detemir) injection

For Single Patient Use Only

100 units/mL (U-100)

For subcutaneous use only

5x3 mL Prefilled Pens

Recommended for use with

NovoFine®, NovoFine® Plus or NovoTwist® disposable needles.

Storage: Refrigerate unused pens at 36°F to 46°F (2°C to 8°C)

in the original carton to protect from light.

Do not freeze. Do not use Levemir® FlexTouch®

if it has been frozen. Store used pen at room temperature

up to 86°F (30°C) and discard after 42 days after first use.

Rx Only

Dispense in this sealed carton.

novo nordisk®

Image of Levemir FlexTouch carton.

PRINCIPAL DISPLAY PANEL

NDC 0169-6432-10 List 643210

Levemir® FlexPen®

(insulin detemir) injection

For Single Patient Use Only

100 units/mL (U-100)

5 x 3 mL Prefilled Pens

For subcutaneous use only

Recommended for use with NovoFine® or NovoFine® Plus disposable needles.

Storage: Refrigerate unused

pens at 36°F to 46°F (2°C to 8°C)

in the original carton to protect from light.

Do not freeze. Do not use Levemir® FlexPen®

if it has been frozen. Store used pen at room temperature

up to 86°F (30°C) and discard after 42 days after first use.

Rx Only

Dispense in this sealed carton.

novo nordisk®

Image of Levemir FlexPen carton