PMDA drug package insert

シタグリプチン錠12.5mg「日新」

PMDA Prescription drug · 日新製薬株式会社 · package insert Aug 17, 2026

Key facts

Brand names シタグリプチン錠12.5mg「日新」, シタグリプチン錠25mg「日新」, シタグリプチン錠50mg「日新」, シタグリプチン錠100mg「日新」
Nonproprietary names シタグリプチンリン酸塩
Companies 製造販売元/日新製薬株式会社
Product type Prescription drug
Therapeutic category 選択的DPP-4阻害剤; ◎糖尿病用剤◎
Therapeutic category codes 873969
YJ codes 39690B2F4052, 39690B2F1053, 39690B2F2050, 39690B2F3056
Approval numbers 30800AMX00283, 30800AMX00284, 30800AMX00285, 30800AMX00286
Package insert edition 第1版
Package insert date Aug 17, 2026
PMDA document key 530113_39690B2F1053_1
PMDA company code 530113

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)