Levemir (Page 8 of 8)

Package Label — Principal Display Panel — 10 mL Vial

Levemir®

Insulin detemir injection

NDC 0169-3687-12

List 368712

100 units/mL (U-100)

For subcutaneous use only

Rx Only

One 10 mL Vial

novo nordisk®

Image of Levemir vial carton
(click image for full-size original)

Package Label — Principal Display Panel – 3 mL FlexTouch

NDC 0169-6438-10 List 643810

Levemir® FlexTouch®

Insulin detemir injection

For Single Patient Use Only

100 units/mL (U-100)

5×3 mL Prefilled Pens

For subcutaneous use only

Rx Only

Recommended for use with

NovoFine® , NovoFine® Plus or

NovoTwist® disposable needles.

Keep in a cold place until first use.

Store at 2° — 8°C (36° — 46°F).

Avoid freezing.

Protect from light.

Dispense in this sealed carton.

FlexTouch
(click image for full-size original)
LEVEMIR
insulin 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 (INSULIN DETEMIR) INSULIN DETEMIR 100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID
GLYCERIN 16 mg in 1 mL
METACRESOL 2.06 mg in 1 mL
PHENOL 1.8 mg in 1 mL
SODIUM CHLORIDE 1.17 mg in 1 mL
SODIUM HYDROXIDE
ZINC 65.4 ug in 1 mL
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 0.89 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0169-3687-12 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
1 10 mL in 1 VIAL, GLASS This package is contained within the CARTON (0169-3687-12)
2 NDC:0169-3687-92 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
2 10 mL in 1 VIAL, GLASS This package is contained within the CARTON (0169-3687-92)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA021536 03/27/2006
LEVEMIR
insulin 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 (INSULIN DETEMIR) INSULIN DETEMIR 100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
ZINC 65.4 ug in 1 mL
METACRESOL 2.06 mg in 1 mL
GLYCERIN 16.0 mg in 1 mL
PHENOL 1.80 mg in 1 mL
SODIUM CHLORIDE 1.17 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 0.89 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0169-6438-10 5 SYRINGE, PLASTIC in 1 CARTON contains a SYRINGE, PLASTIC
1 3 mL in 1 SYRINGE, PLASTIC This package is contained within the CARTON (0169-6438-10)
2 NDC:0169-6438-97 1 SYRINGE, PLASTIC in 1 CARTON contains a SYRINGE, PLASTIC (0169-6438-90)
2 NDC:0169-6438-90 3 mL in 1 SYRINGE, PLASTIC This package is contained within the CARTON (0169-6438-97)
3 NDC:0169-6438-98 1 SYRINGE, PLASTIC in 1 CARTON contains a SYRINGE, PLASTIC (0169-6438-90)
3 NDC:0169-6438-90 3 mL in 1 SYRINGE, PLASTIC This package is contained within the CARTON (0169-6438-98)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA021536 10/31/2013
Labeler — Novo Nordisk (622920320)

Revised: 04/2021 Novo Nordisk

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.