Palonosetron Hydrochloride (Page 7 of 7)

Palonosetron Hydrochloride Injection 0.25 mg/5 mL, 10-Pack Carton Text

NDC 69543-371 -10
Rx only

Palonosetron Hydrochloride Injection
0.25 mg/5 mL (0.05 mg*/mL)
For intravenous injection only.

VIRTUS®
PHARMACEUTICALS

10 x 5 mLSingle Dose Vials

PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69543-371
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PALONOSETRON HYDROCHLORIDE (PALONOSETRON) PALONOSETRON 0.25 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL
EDETATE DISODIUM
CITRIC ACID MONOHYDRATE
TRISODIUM CITRATE DIHYDRATE
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69543-371-10 10 CARTON in 1 BOX contains a CARTON (69543-371-01)
1 NDC:69543-371-01 1 VIAL in 1 CARTON This package is contained within the BOX (69543-371-10) and contains a VIAL
1 5 mL in 1 VIAL This package is contained within a CARTON (69543-371-01) and a BOX (69543-371-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209287 09/19/2018 01/31/2026
Labeler — Virtus Pharmaceuticals, LLC (079659493)
Establishment
Name Address ID/FEI Operations
Rafarm S.A. 506963742 manufacture (69543-371)

Revised: 10/2023 Virtus Pharmaceuticals, LLC

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