Magnevist (Page 6 of 6)

Package/Label Display Panel: PFS 10 mL

PFS 10 mL
(click image for full-size original)

NDC 50419-188-36

sterile solution

10 mL

5 prefilled syringes of 10 mL

Magnevist®

(brand of gadopentetate dimeglumine) injection

Rx only

Prefilled Disposable 10 mL Syringe.

FOR INTRAVENOUS USE.

Single dose syringe.

Discard unused portion and syringe.

MEDICATION AND FLUID PATHWAY ARE STERILE. OUTSIDE OF SYRINGE IS NOT STERILE.

Usual Dosage: See package insert.

Protect from light. Store at controlled room temperature, between 15–30°C (59–86°F). DO NOT FREEZE.

Each mL contains 469.01 mg gadopentetate dimeglumine, 0.99 mg meglumine, 0.40 mg diethylenetriamine pentaacetic acid and water for injection. Magnevist® Injection contains no antimicrobial preservative.

Discard contents if either syringe seat is broken or syringe seal is observed to be broken or leaking.

Mfd. for:

Bayer HealthCare Pharmaceuticals Inc.
Whippany, NJ 07981
Mfd. in Germany

10 mL
Injection

10 mL

Package/Label Display Panel: PFS 15 mL

PFS 15 mL
(click image for full-size original)

NDC 50419-188-37

sterile solution

15 mL

5 prefilled syringes of 15 mL

Magnevist®

(brand of gadopentetate dimeglumine) injection

Rx only

Prefilled Disposable 15 mL Syringe.

FOR INTRAVENOUS USE.

Single dose syringe.

Discard unused portion and syringe.

MEDICATION AND FLUID PATHWAY ARE STERILE. OUTSIDE OF SYRINGE IS NOT STERILE.

Usual Dosage: See package insert.

Protect from light. Store at controlled room temperature, between 15–30°C (59–86°F). DO NOT FREEZE.

Each mL contains 469.01 mg gadopentetate dimeglumine, 0.99 mg meglumine, 0.40 mg diethylenetriamine pentaacetic acid and water for injection. Magnevist® Injection contains no antimicrobial preservative.

Discard contents if either syringe seat is broken or syringe seal is observed to be broken or leaking.

Manufactured for:

Bayer HealthCare Pharmaceuticals Inc.
Whippany, NJ 07981
Mfd. in Germany

15 mL
Injection

15 mL

Package/Label Display Panel: PFS 20 mL

PFS 20 mL
(click image for full-size original)

NDC 50419-188-38

sterile solution

20 mL

5 prefilled syringes of 20 mL

Magnevist®

(brand of gadopentetate dimeglumine) injection

Rx only

Prefilled Disposable 20 mL Syringe.

FOR INTRAVENOUS USE.

Single dose syringe.

Discard unused portion and syringe.

MEDICATION AND FLUID PATHWAY ARE STERILE. OUTSIDE OF SYRINGE IS NOT STERILE.

Usual Dosage: See package insert.

Protect from light. Store at controlled room temperature, between 15–30°C (59–86°F). DO NOT FREEZE.

Each mL contains 469.01 mg gadopentetate dimeglumine, 0.99 mg meglumine, 0.40 mg diethylenetriamine pentaacetic acid and water for injection. Magnevist® Injection contains no antimicrobial preservative.

Discard contents if either syringe seat is broken or syringe seal is observed to be broken or leaking.

Manufactured for:

Bayer HealthCare Pharmaceuticals Inc.
Whippany, NJ 07981
Mfd. in Germany

20 mL
Injection

20 mL

MAGNEVIST
gadopentetate dimeglumine injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50419-188
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GADOPENTETATE DIMEGLUMINE (GADOPENTETATE) GADOPENTETATE DIMEGLUMINE 469.01 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MEGLUMINE 0.99 mg in 1 mL
WATER
PENTETIC ACID 0.4 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50419-188-47 5 SYRINGE in 1 BOX contains a SYRINGE
1 20 mL in 1 SYRINGE This package is contained within the BOX (50419-188-47)
2 NDC:50419-188-38 5 SYRINGE in 1 BOX contains a SYRINGE
2 20 mL in 1 SYRINGE This package is contained within the BOX (50419-188-38)
3 NDC:50419-188-46 20 CARTON in 1 BOX contains a CARTON
3 1 VIAL, SINGLE-DOSE in 1 CARTON This package is contained within the BOX (50419-188-46) and contains a VIAL, SINGLE-DOSE
3 20 mL in 1 VIAL, SINGLE-DOSE This package is contained within a CARTON and a BOX (50419-188-46)
4 NDC:50419-188-02 20 CARTON in 1 BOX contains a CARTON
4 1 VIAL, SINGLE-DOSE in 1 CARTON This package is contained within the BOX (50419-188-02) and contains a VIAL, SINGLE-DOSE
4 20 mL in 1 VIAL, SINGLE-DOSE This package is contained within a CARTON and a BOX (50419-188-02)
5 NDC:50419-188-45 5 SYRINGE in 1 BOX contains a SYRINGE
5 15 mL in 1 SYRINGE This package is contained within the BOX (50419-188-45)
6 NDC:50419-188-37 5 SYRINGE in 1 BOX contains a SYRINGE
6 15 mL in 1 SYRINGE This package is contained within the BOX (50419-188-37)
7 NDC:50419-188-44 20 CARTON in 1 BOX contains a CARTON
7 20 VIAL, SINGLE-DOSE in 1 CARTON This package is contained within the BOX (50419-188-44) and contains a VIAL, SINGLE-DOSE
7 15 mL in 1 VIAL, SINGLE-DOSE This package is contained within a CARTON and a BOX (50419-188-44)
8 NDC:50419-188-15 20 CARTON in 1 BOX contains a CARTON
8 1 VIAL, SINGLE-DOSE in 1 CARTON This package is contained within the BOX (50419-188-15) and contains a VIAL, SINGLE-DOSE
8 15 mL in 1 VIAL, SINGLE-DOSE This package is contained within a CARTON and a BOX (50419-188-15)
9 NDC:50419-188-43 5 SYRINGE in 1 BOX contains a SYRINGE
9 10 mL in 1 SYRINGE This package is contained within the BOX (50419-188-43)
10 NDC:50419-188-36 5 SYRINGE in 1 BOX contains a SYRINGE
10 10 mL in 1 SYRINGE This package is contained within the BOX (50419-188-36)
11 NDC:50419-188-42 20 CARTON in 1 BOX contains a CARTON
11 1 VIAL, SINGLE-DOSE in 1 CARTON This package is contained within the BOX (50419-188-42) and contains a VIAL, SINGLE-DOSE
11 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within a CARTON and a BOX (50419-188-42)
12 NDC:50419-188-01 20 CARTON in 1 BOX contains a CARTON
12 1 VIAL, SINGLE-DOSE in 1 CARTON This package is contained within the BOX (50419-188-01) and contains a VIAL, SINGLE-DOSE
12 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within a CARTON and a BOX (50419-188-01)
13 NDC:50419-188-40 20 CARTON in 1 BOX contains a CARTON
13 1 VIAL, SINGLE-DOSE in 1 CARTON This package is contained within the BOX (50419-188-40) and contains a VIAL, SINGLE-DOSE
13 5 mL in 1 VIAL, SINGLE-DOSE This package is contained within a CARTON and a BOX (50419-188-40)
14 NDC:50419-188-05 20 CARTON in 1 BOX contains a CARTON
14 1 VIAL, SINGLE-DOSE in 1 CARTON This package is contained within the BOX (50419-188-05) and contains a VIAL, SINGLE-DOSE
14 5 mL in 1 VIAL, SINGLE-DOSE This package is contained within a CARTON and a BOX (50419-188-05)
15 NDC:50419-188-81 2 CARTON in 1 BOX contains a CARTON
15 10 VIAL, SINGLE-DOSE in 1 CARTON This package is contained within the BOX (50419-188-81) and contains a VIAL, SINGLE-DOSE
15 5 mL in 1 VIAL, SINGLE-DOSE This package is contained within a CARTON and a BOX (50419-188-81)
16 NDC:50419-188-82 2 CARTON in 1 BOX contains a CARTON
16 10 VIAL, SINGLE-DOSE in 1 CARTON This package is contained within the BOX (50419-188-82) and contains a VIAL, SINGLE-DOSE
16 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within a CARTON and a BOX (50419-188-82)
17 NDC:50419-188-83 2 CARTON in 1 BOX contains a CARTON
17 10 VIAL, SINGLE-DOSE in 1 CARTON This package is contained within the BOX (50419-188-83) and contains a VIAL, SINGLE-DOSE
17 15 mL in 1 VIAL, SINGLE-DOSE This package is contained within a CARTON and a BOX (50419-188-83)
18 NDC:50419-188-84 2 CARTON in 1 BOX contains a CARTON
18 10 VIAL, SINGLE-DOSE in 1 CARTON This package is contained within the BOX (50419-188-84) and contains a VIAL, SINGLE-DOSE
18 20 mL in 1 VIAL, SINGLE-DOSE This package is contained within a CARTON and a BOX (50419-188-84)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019596 06/11/2014 01/31/2023
Labeler — Bayer HealthCare Pharmaceuticals Inc. (005436809)
Establishment
Name Address ID/FEI Operations
Bayer AG 315097875 ANALYSIS (50419-188), API MANUFACTURE (50419-188), LABEL (50419-188), MANUFACTURE (50419-188), PACK (50419-188), STERILIZE (50419-188)

Revised: 07/2019 Bayer HealthCare Pharmaceuticals Inc.

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