The U.S. Food and Drug Administration (FDA) has granted approval for application ANDA078127 covering an oral solution of ondansetron (ondansetron hydrochloride) at a strength of 4 mg per 5 mL. The product is marketed under the brand name ONDANSETRON by PAI Holdings, LLC dba PAI Pharma and is classified as a prescription human drug.
The approved product is administered orally in a solution dosage form. It is identified by several National Drug Code (NDC) numbers, including 0121-0882-51, 0121-4882-05, and 0121-4882-94, and carries the UNII NMH84OZK2B and RxCUI 312085. The active ingredient listed is ondansetron hydrochloride, equivalent to 4 mg base per 5 mL.
The submission history shows an original submission (submission number 1) filed on 2007‑06‑25, followed by multiple labeling supplements (submission numbers 4, 5, 6, 7, 8, 9, 10, 12) ranging from 2013 to 2025, all with a standard review priority and status “AP”. A manufacturing (CMC) supplement (submission number 14) is recorded with an approval status dated 2026‑04‑03.
Regulatory UpdatesSep 18, 2026•3 min read
FDA Approves ANDA078127 for Ondansetron Oral Solution
The FDA has approved application ANDA078127 for an oral ondansetron solution (4 mg/5 mL) marketed by PAI Holdings, LLC dba PAI Pharma.
Compiled by the Pharmacountry team · Source: FDA.gov
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