CLARISCAN: Package Insert and Label Information (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 10 mL Vial Label

NDC 0407-2943-01
Rx Only

Clariscan™
(gadoterate meglumine) Injection

5 mmol per 10 mL
(0.5 mmol per mL)

For Intravenous Administration Discard Unused Portion

10 mL Single-dose Vial

PRINCIPAL DISPLAY PANEL -- 10 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mL Vial Box Label

NDC 0407-2943-01

Rx Only

Clariscan™
(gadoterate meglumine) Injection

5 mmol per 10 mL
(0.5 mmol per mL)

For Intravenous Administration
Sterile Solution
Discard Unused Portion

10 x 10 mL Single-dose Vials

5 mmol per 10 mL
(0.5 mmol per mL)

Usual Dosage — See Package Insert.
Store at 25°C (77°F); excursions permitted
to 15°C to 30°C (59°F to 86°F) [see USP,
Controlled Room Temperature].

Each mL contains 376.9 mg of gadoterate
meglumine, 0.25 mg of DOTA and water for injection.

Distributed by GE Healthcare Inc.,
Marlborough, MA 01752 U.S.A.
For inquiries call 1-800-654-0118Product of Norwegian Origin

GE Healthcare

C-110

PRINCIPAL DISPLAY PANEL -- 10 mL Vial Box Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 15 mL Syringe Label

NDC 0407-2943-17

Rx Only

Clariscan™
(gadoterate meglumine) Injection

7.5 mmol per 15 mL
(0.5 mmol per mL)

Sterile Solution
For Intravenous Administration
Discard Unused Portion

15 mL Single-Dose Plastic Syringe

PRINCIPAL DISPLAY PANEL -- 15 mL Syringe Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 15 mL Syringe Box Label

NDC 0407-2943-17

Rx Only

Clariscan™
(gadoterate meglumine) Injection

7.5 mmol per 15 mL
(0.5 mmol per mL)

Sterile Solution
For Intravenous Administration
Discard Unused Portion

1 x 15 mL Single-Dose Plastic Syringe

PRINCIPAL DISPLAY PANEL -- 15 mL Syringe Box Label
(click image for full-size original)
CLARISCAN gadoterate meglumine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0407-2943
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
gadoterate meglumine (GADOLINIUM CATION (3+)) GADOLINIUM CATION (3+) 376.9 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER 1 mL in 1 mL
TETRAXETAN 0.25 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0407-2943-01 10 VIAL, GLASS in 1 BOX contains a VIAL, GLASS
1 10 mL in 1 VIAL, GLASS This package is contained within the BOX (0407-2943-01)
2 NDC:0407-2943-02 10 VIAL, GLASS in 1 BOX contains a VIAL, GLASS
2 15 mL in 1 VIAL, GLASS This package is contained within the BOX (0407-2943-02)
3 NDC:0407-2943-05 10 VIAL, GLASS in 1 BOX contains a VIAL, GLASS
3 20 mL in 1 VIAL, GLASS This package is contained within the BOX (0407-2943-05)
4 NDC:0407-2943-06 10 VIAL, GLASS in 1 BOX contains a VIAL, GLASS
4 5 mL in 1 VIAL, GLASS This package is contained within the BOX (0407-2943-06)
5 NDC:0407-2943-12 10 SYRINGE, PLASTIC in 1 BOX contains a SYRINGE, PLASTIC
5 10 mL in 1 SYRINGE, PLASTIC This package is contained within the BOX (0407-2943-12)
6 NDC:0407-2943-17 10 SYRINGE, PLASTIC in 1 BOX contains a SYRINGE, PLASTIC
6 15 mL in 1 SYRINGE, PLASTIC This package is contained within the BOX (0407-2943-17)
7 NDC:0407-2943-22 10 SYRINGE, PLASTIC in 1 BOX contains a SYRINGE, PLASTIC
7 20 mL in 1 SYRINGE, PLASTIC This package is contained within the BOX (0407-2943-22)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210016 11/01/2019
Labeler — GE Healthcare (053046579)
Establishment
Name Address ID/FEI Operations
GE Healthcare AS 515048908 MANUFACTURE (0407-2943), RELABEL (0407-2943), REPACK (0407-2943), ANALYSIS (0407-2943)
Establishment
Name Address ID/FEI Operations
GE Healthcare Lindesnes 518890970 API MANUFACTURE (0407-2943)

Revised: 12/2020 GE Healthcare

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