Home NDC 69097-292 Cyclosporine
Product NDC 69097-292
11-digit product format 690970292
Labeler code 69097
Product ID 69097-292_4aa71224-130e-44e0-953c-1f6de85e6d22
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclosporine
Dosage form EMULSION
Route OPHTHALMIC
Labeler Cipla USA Inc.
Application ANDA219288
Marketing category ANDA
Marketing start 2026-09-21
Substance CYCLOSPORINE
Active strength .5 mg/mL
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 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219288-001 CYCLOSPORINE CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2026-06-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219288-001 AB
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 2026-09-14 22:38:34 2026-08 A219288-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2026-06-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219288-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2026-06-01 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219288-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2026-06-01 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A219288-001 AB 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219288-001 AB 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219288-001 AB 1 a50c72e98297…
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 .5 mg/mL
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69097-292-03 69097029203 2 POUCH in 1 CARTON (69097-292-03) / 30 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE 2 pouch 2026-09-21 No No Current 69097-292-97 69097029297 1 POUCH in 1 CARTON (69097-292-97) / 30 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE 1 pouch 2026-09-21 No No Current