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Phenytoin Sodium

Phenytoin Sodium

6 ACTIVE SUPPLIERS — US
openFDA · updated weekly
US11 NDCs
6 active makers
UKComing
soon
CAComing
soon
AUComing
soon
EUComing
soon
RxCUI (US)8183
US makers6 labelers
Packages15
DEA / ScheduleNone

Medicaid dispensing volumeSDUD · per quarter

Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.

183654722025 Q12025 Q22025 Q32025 Q42026 Q1
12
Rx · 2026 Q1
196
Units dispensed
-81%
Rx vs. year ago
5
Quarters · since 2025 Q1

Who makes it6 active · 0 exited

US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.

LabelerTypePackagesStatus
Hikma Pharmaceuticals USA Inc.unknown6SUPPLYING
HF Acquisition Co LLC, DBA HealthFirstunknown3SUPPLYING
Acella Pharmaceuticals, LLCunknown2SUPPLYING
Henry Schein Inc.unknown2SUPPLYING
ProPharma Distributionunknown1SUPPLYING
Medical Purchasing Solutions, LLCunknown1SUPPLYING

Regulatory & supply eventsFDA · US

Shortages, recalls, and registration changes attached to this drug concept.

  • Nov 14, 2022
    RECALLRecall (Class III): Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10…

    Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode. — Recalling firm: Acella Pharmaceuticals, LLC — Nationwide in the USA.

  • Nov 14, 2022
    RECALLRecall (Class III): Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-3…

    Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode. — Recalling firm: Acella Pharmaceuticals, LLC — Nationwide in the USA.