Gadavist (Page 11 of 11)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Gadavist Pharmacy Bulk Pack 65 mL Label

Dose: 0.1 mL/kg

NDC 50419-325-05
65 mL

Rx only

sterile solution

Gadavist

sterile solution

Gadavist

(gadobutrol) injection
1 mmol/mL

For Intravenous Administration.Multi-dose container.

Discard unused portion 24 hours after initial puncture.

65 Ml LABEL
(click image for full-size original)
GADAVIST gadobutrol injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50419-325
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GADOBUTROL (GADOLINIUM CATION (3+)) GADOBUTROL 604.72 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
TROMETHAMINE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50419-325-14 2 CARTON in 1 BOX contains a CARTON
1 5 BOTTLE, GLASS in 1 CARTON This package is contained within the BOX (50419-325-14) and contains a BOTTLE, GLASS
1 30 mL in 1 BOTTLE, GLASS This package is contained within a CARTON and a BOX (50419-325-14)
2 NDC:50419-325-15 10 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS
2 65 mL in 1 BOTTLE, GLASS This package is contained within the BOX (50419-325-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201277 03/14/2011
Labeler — Bayer HealthCare Pharmaceuticals Inc. (005436809)
Registrant — Bayer HealthCare Pharmaceuticals Inc. (828111489)
Establishment
Name Address ID/FEI Operations
Bayer AG 315097875 ANALYSIS (50419-325), API MANUFACTURE (50419-325), LABEL (50419-325), MANUFACTURE (50419-325), PACK (50419-325), STERILIZE (50419-325)

Revised: 08/2020 Bayer HealthCare Pharmaceuticals Inc.

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