PMDA drug package insert

アモキシシリンカプセル125mg「TCK」

PMDA Prescription drug · 辰巳化学株式会社 · package insert Aug 29, 2025

Key facts

Brand names アモキシシリンカプセル125mg「TCK」, アモキシシリンカプセル250mg「TCK」
Nonproprietary names アモキシシリン水和物
Companies 製造販売元/辰巳化学株式会社
Product type Prescription drug
Therapeutic category 合成ペニシリン製剤
Therapeutic category codes 876131
YJ codes 6131001M1142, 6131001M2351
Approval numbers 23000AMX00567000, 23000AMX00568000
Package insert edition 第4版
Package insert date Aug 29, 2025
PMDA document key 400278_6131001M1142_1
PMDA company code 400278

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:

Browse all PMDA approved drugs and package inserts (Japan)