PMDA drug package insert
ヒダントール錠25mg
PMDA Prescription drug · 藤永製薬株式会社 · package insert Apr 21, 2026
Key facts
| Brand names | ヒダントール錠25mg, ヒダントール錠100mg |
|---|---|
| Nonproprietary names | フェニトイン |
| Companies | 製造販売元／藤永製薬株式会社, 販売元／第一三共株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗てんかん剤 |
| Therapeutic category codes | 871132 |
| YJ codes | 1132002F1029, 1132002F2033 |
| Approval numbers | 16000AMZ00891, 16000AMZ00892 |
| Package insert edition | 第3版 |
| Package insert date | Apr 21, 2026 |
| PMDA document key | 670126_1132002F1029_1 |
| PMDA company code | 670126 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- No PMDA review report published
- No Risk management plan (RMP)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMDA approved drugs and package inserts (Japan)
Japan's PMDA publishes the package insert (添付文書) of every prescription drug, OTC drug and regenerative medical product, with brand and nonproprietary names, YJ codes and approval numbers. Names appear in Japanese as published.
Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, package insert database · Source date: