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.

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.