FUROSEMIDE (Page 3 of 3)

PRINCIPAL DISPLAY PANEL — 51662-1574-3 CASE LABELING AND SERIALIZED LABELING

51662-1574-3 CASE AND SERILIZED LABELING

CASE
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SERIALIZED CASE
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FUROSEMIDE furosemide injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1574(NDC:63323-280)
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUROSEMIDE (FUROSEMIDE) FUROSEMIDE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID
SODIUM CHLORIDE
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51662-1574-1 4 mL in 1 VIAL None
2 NDC:51662-1574-3 25 POUCH in 1 CASE contains a POUCH (51662-1574-2)
2 NDC:51662-1574-2 1 VIAL in 1 POUCH This package is contained within the CASE (51662-1574-3) and contains a VIAL
2 4 mL in 1 VIAL This package is contained within a POUCH (51662-1574-2) and a CASE (51662-1574-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018902 06/28/2021
Labeler — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Registrant — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Establishment
Name Address ID/FEI Operations
HF Acquisition Co LLC, DBA HealthFirst 045657305 relabel (51662-1574)

Revised: 07/2021 HF Acquisition Co LLC, DBA HealthFirst

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