Source: FDA, National Drug Code (US) Revision Year: 2020
Levoleucovorin is a folate analog and the pharmacologically active levo-isomer of d,l-leucovorin. The chemical name is (2S)2[[4-[[(6S)-2-amino-5-formyl-4-oxo-1,6,7,8-tetrahydropteridin-6- yl] methylamino] benzoyl] amino] pentanedioate. The molecular formula is C20H23N7O7 and the molecular weight is 473.45.
The molecular structure is:
Levoleucovorin is a slightly hygroscopic, crystalline, yellow powder which is soluble in water when pH is at or above 8.
KHAPZORY 175 mg is a sterile lyophilized powder consisting of 175 mg levoleucovorin, 29.6 mg sodium hydroxide, and 105 mg mannitol in each vial. Additional sodium hydroxide and/or hydrochloric acid may be used to adjust the pH during manufacture. It is intended for intravenous administration after reconstitution with 3.6 mL of sterile 0.9% Sodium Chloride Injection, USP.
KHAPZORY 300 mg is a sterile lyophilized powder consisting of 300 mg levoleucovorin, 50.7 mg sodium hydroxide, and 180 mg mannitol in each vial. Additional sodium hydroxide and/or hydrochloric acid may be used to adjust the pH during manufacture. It is intended for intravenous administration after reconstitution with 6.2 mL of sterile 0.9% Sodium Chloride Injection, USP.
| Dosage Forms and Strengths |
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For injection: 175 mg and 300 mg of levoleucovorin as a sterile, white to yellowish lyophilized powder in a single-dose vial for reconstitution. |
| How Supplied |
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KHAPZORY (levoleucovorin) for injection is a sterile, preservative-free, white to yellowish lyophilized powder in a single-dose vial. It is available as: 175 mg vial – NDC 72893-004-01 Distributed by: Acrotech Biopharma LLC, East Windsor, NJ 08520 |
| Drug | Countries | |
|---|---|---|
| KHAPZORY | United States |
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