NovoLog (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 3 mL NovoLog FlexPen

NDC 68258-8899-03

NovoLog® FlexPen®

Prefilled Syringe

Insulin aspart Injection (rDNA origin)

100 units/mL (U-100)

5 x 3 mL Prefilled Insulin Syringes

Rx only

Single patient use only

For use with NovoFine® disposable needles.

Keep in a cold place. Avoid freezing.

Protect from light.

NDC 68258-8899-03
(click image for full-size original)

NOVOLOG
insulin aspart injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68258-8899(NDC:0169-6339)
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN ASPART (INSULIN ASPART) INSULIN ASPART 100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 1.25 mg in 1 mL
GLYCERIN 16 mg in 1 mL
HYDROCHLORIC ACID
METACRESOL 1.72 mg in 1 mL
PHENOL 1.5 mg in 1 mL
SODIUM CHLORIDE 0.58 mg in 1 mL
SODIUM HYDROXIDE
ZINC 19.6 ug in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68258-8899-3 3 mL in 1 SYRINGE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020986 01/22/2003
Labeler — Dispensing Solutions, Inc. (066070785)
Registrant — PSS World Medical, Inc. (101822682)
Establishment
Name Address ID/FEI Operations
Dispensing Solutions, Inc. 066070785 relabel (68258-8899), repack (68258-8899)

Revised: 07/2013 Dispensing Solutions, Inc.

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