OMNISCAN (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 10 mL Vial Label

GE Healthcare

NDC 0407-0690-10

OMNISCAN™
(gadodiamide) Injection

10 mL 287 mg/mL

10 mL Single-Dose Vial

Sterile Aqueous Injection

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

PRINCIPAL DISPLAY PANEL — 15 mL Syringe Box Label

GE Healthcare

OMNISCAN™
(gadodiamide) Injection

Prefill Plus™ needle-free system

15 mL
287 mg/mL

NDC 0407-0691-62

CONTAINS:
1 — Omniscan™ 15 mL fill in 20 mL Single Dose Prefilled Syringe
1 — 5 mL 0.9% Sodium Chloride (0.9% NaCl) I.V. Flush Syringe
OMNISCAN (gadodiamide) Injection – Each 1 mL contains 287 mg gadodiamide, 12 mg
caldiamide sodium, in Water for Injection. The pH is adjusted between 5.5 and 7.0 with
hydrochloric acid or sodium hydroxide.
No preservative added. For intravenous use only. Each syringe for one procedure only.
Discard unused portion.
O.9% Sodium Chloride (0.9% NaCl) – Each Sterile Flush Syringe contains a sterile isotonic
solution of 0.9% Sodium Chloride (0.9% NaCl). Each mL contains 9 mg sodium chloride.
The osmolarity is 0.308 mOsmol/mL (calc.). Preservative free. For I.V. flush only.

Do not use if solution is discolored or contains a precipitate.
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP]. Protect from light. Do not freeze. For indications and dosage, see package insert. Rx ONLY.

Exp.:

Lot:

1192196 USA

PRINCIPAL DISPLAY PANEL -- 15 mL Syringe Box Label
(click image for full-size original)
OMNISCAN gadodiamide injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0407-0690
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
gadodiamide (gadodiamide) gadodiamide 287 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
caldiamide sodium 12 mg in 1 mL
hydrochloric acid
sodium hydroxide
Product Characteristics
Color YELLOW (Clear, colorless to slightly yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0407-0690-05 10 VIAL in 1 BOX contains a VIAL
1 5 mL in 1 VIAL This package is contained within the BOX (0407-0690-05)
2 NDC:0407-0690-10 10 VIAL in 1 BOX contains a VIAL
2 10 mL in 1 VIAL This package is contained within the BOX (0407-0690-10)
3 NDC:0407-0690-15 10 VIAL in 1 BOX contains a VIAL
3 15 mL in 1 VIAL This package is contained within the BOX (0407-0690-15)
4 NDC:0407-0690-20 10 VIAL in 1 BOX contains a VIAL
4 20 mL in 1 VIAL This package is contained within the BOX (0407-0690-20)
5 NDC:0407-0690-12 10 SYRINGE, PLASTIC in 1 BOX contains a SYRINGE, PLASTIC
5 10 mL in 1 SYRINGE, PLASTIC This package is contained within the BOX (0407-0690-12)
6 NDC:0407-0690-17 10 SYRINGE, PLASTIC in 1 BOX contains a SYRINGE, PLASTIC
6 15 mL in 1 SYRINGE, PLASTIC This package is contained within the BOX (0407-0690-17)
7 NDC:0407-0690-22 10 SYRINGE, PLASTIC in 1 BOX contains a SYRINGE, PLASTIC
7 20 mL in 1 SYRINGE, PLASTIC This package is contained within the BOX (0407-0690-22)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020123 04/19/2002
OMNISCAN gadodiamide injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0407-0691
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
gadodiamide (gadodiamide) gadodiamide 287 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
caldiamide sodium 12 mg in 1 mL
hydrochloric acid
sodium hydroxide
Product Characteristics
Color YELLOW (Clear, colorless to slightly yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0407-0691-62 10 SYRINGE, PLASTIC in 1 BOX contains a SYRINGE, PLASTIC
1 15 mL in 1 SYRINGE, PLASTIC This package is contained within the BOX (0407-0691-62)
2 NDC:0407-0691-63 10 SYRINGE, PLASTIC in 1 BOX contains a SYRINGE, PLASTIC
2 20 mL in 1 SYRINGE, PLASTIC This package is contained within the BOX (0407-0691-63)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020123 09/21/2006
Labeler — GE Healthcare Inc. (053046579)
Establishment
Name Address ID/FEI Operations
GE Healthcare AS 515048908 MANUFACTURE (0407-0690), MANUFACTURE (0407-0691), REPACK (0407-0690), REPACK (0407-0691), RELABEL (0407-0690), RELABEL (0407-0691), ANALYSIS (0407-0690), ANALYSIS (0407-0691)
Establishment
Name Address ID/FEI Operations
GE Healthcare Ireland Limited 988006565 MANUFACTURE (0407-0690), REPACK (0407-0690), RELABEL (0407-0690), ANALYSIS (0407-0690)
Establishment
Name Address ID/FEI Operations
GE Healthcare Shanghai Co., Ltd. 545292716 MANUFACTURE (0407-0690), REPACK (0407-0690), RELABEL (0407-0690), ANALYSIS (0407-0690)
Establishment
Name Address ID/FEI Operations
GE Healthcare AS 518890970 API MANUFACTURE (0407-0690), API MANUFACTURE (0407-0691)

Revised: 05/2020 GE Healthcare Inc.

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.