Home NDC 59651-927-03 Cyclosporine
Product NDC 59651-927
Requested package NDC 59651-927-03
11-digit product format 596510927
Labeler code 59651
Product ID 59651-927_aaf79e72-26bf-4152-9cd1-10d8c30fa4fe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclosporine
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA219652
Marketing category ANDA
Marketing start 2026-09-17
Substance CYCLOSPORINE
Active strength 25 mg/1
Pharmacologic classes Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219652-001 CYCLOSPORINE CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2026-09-17 A219652-002 CYCLOSPORINE CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2026-09-17 A219652-003 CYCLOSPORINE CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2026-09-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A219652-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2026-09-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219652-002 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2026-09-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219652-003 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2026-09-17 c2088c7a36db…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Cyclosporine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYCLOSPORINE 25 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59651-927-03 59651092703 3 BLISTER PACK in 1 CARTON (59651-927-03) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 3 blister pack 2026-09-17 No No Current