Home NDC 67184-0585 Cyclosporine
Product NDC 67184-0585
11-digit product format 671840585
Labeler code 67184
Product ID 67184-0585_9efba233-f757-4c18-bdcb-2c4a5af05bdc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclosporine
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Qilu Pharmaceutical Co., Ltd.
Application ANDA219049
Marketing category ANDA
Marketing start 2025-09-15
Substance CYCLOSPORINE
Active strength 100 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219049-001 CYCLOSPORINE CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2025-09-15 A219049-002 CYCLOSPORINE CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2025-09-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 A219049-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2025-09-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219049-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2025-09-15 c2088c7a36db…2026-09-14 22:38:34 2026-08 A219049-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2025-09-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219049-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2025-09-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219049-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2025-09-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219049-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2025-09-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219049-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2025-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219049-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2025-09-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219049-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2025-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219049-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2025-09-15 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219049-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2025-09-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219049-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2025-09-15 a50c72e98297…
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 100 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 67184-0585-1 67184058501 5 BLISTER PACK in 1 CARTON (67184-0585-1) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (67184-0585-0) 5 blister pack 2025-09-15 No No Current