Source: FDA, National Drug Code (US) Revision Year: 2022
IDAMYCIN PFS Injection contains idarubicin hydrochloride and is a sterile, semi-synthetic, preservative-free solution (PFS) antineoplastic anthracycline for intravenous use. Chemically, idarubicin hydrochloride is 5, 12-Naphthacenedione, 9-acetyl-7-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,9,11-trihydroxyhydrochloride, (7S-cis). The structural formula is as follows:
C26H27NO9 ∙ HCL M.W. 533.96
IDAMYCIN PFS is a sterile, red-orange, isotonic parenteral preservative-free solution, available in 5 mL (5 mg), 10 mL (10 mg) and 20 mL (20 mg) single-dose only vials.
Each mL contains Idarubicin HCL, USP 1 mg (equivalent to 0.93 mg Idarubicin free base) and the following inactive ingredients: Glycerin, USP 25 mg and Water for Injection, USP q.s. Hydrochloric Acid, NF is used to adjust the pH to a target of 3.5.
| How Supplied |
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IDAMYCIN PFS Injection (idarubicin hydrochloride injection). Single Dose Cytosafe Vials: Sterile single-dose only, contains no preservative. Discard unused portion. NDC 0013-2576-91 5 mg/5 mL vial (1 mg/mL), single-dose vials. Distributed by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10017 |
| Drug | Countries | |
|---|---|---|
| IDAMYCIN | Japan, Mexico, United States |
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