Norditropin (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — NORDITROPIN NORDIFLEX 5 MG/1.5ML

Norditropin NordiFlex®

Somatropin (rDNA origin) injection

5 mg/1.5 mL Prefilled Pen

1 x 1.5 mL prefilled disposable pen

Each 1.5 mL contains 5 mg somatropin

CONTAINS ONE

NORDITROPIN NORDIFLEX® 5 mg/1.5 mL

Rx ONLY

List: 770411

Before use MUST keep refrigerated. (2ºC-8ºC/36ºF-46ºF). Do not store with needles. After initial injection, EITHER keep refrigerated for 4 weeks OR store not above 25ºC (77ºF) for 3 weeks. Do not freeze. Discard unused portion. Avoid direct light. Keep out of the reach and sight of children. For subcutaneous administration only. Please read the enclosed leaflet before use.

Norditropin NordiFlex 5 mg/1.5 mL
(click image for full-size original)
NORDITROPIN somatropin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6146(NDC:0169-7704)
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOMATROPIN (SOMATROPIN) SOMATROPIN 5 mg in 1.5 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE 1 mg in 1.5 mL
HYDROCHLORIC ACID
MANNITOL 60 mg in 1.5 mL
PHENOL 4.5 mg in 1.5 mL
POLOXAMER 188 4.5 mg in 1.5 mL
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6146-0 1 SYRINGE, PLASTIC (SYRINGE) in 1 CARTON contains a SYRINGE, PLASTIC
1 1.5 mL in 1 SYRINGE, PLASTIC This package is contained within the CARTON (54868-6146-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021148 08/10/2010
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 03/2010 Physicians Total Care, Inc.

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