Home NDC 71656-012 CYCLOSPORINE
Product NDC 71656-012
11-digit product format 716560012
Labeler code 71656
Product ID 71656-012_458a84bc-12a1-5159-e063-6394a90ac45c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CYCLOSPORINE
Dosage form EMULSION
Route OPHTHALMIC
Labeler Saptalis Pharmaceuticals, LLC
Application ANDA211943
Marketing category ANDA
Marketing start 2025-12-12
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A211943-001 CYCLOSPORINE CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2024-07-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211943-001 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 2026-02-19 14:30 UTC 2026-02 A211943-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2024-07-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211943-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2024-07-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211943-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2024-07-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211943-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2024-07-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211943-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2024-07-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211943-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2024-07-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211943-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2024-07-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211943-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2024-07-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211943-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2024-07-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211943-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2024-07-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211943-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2024-07-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211943-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2024-07-05 301d65b070ca…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211943-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2024-07-05 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base CYCLOSPORINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYCLOSPORINE .5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 83HN0GTJ6D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2572292 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71656-012-30 CYCLOSPORINE 5 in 1 POUCH EMULSION 5 1 71656-012-30 CYCLOSPORINE 6 in 1 CARTON EMULSION 6 1 71656-012-60 CYCLOSPORINE 12 in 1 CARTON EMULSION 12 1 71656-012-60 CYCLOSPORINE 5 in 1 POUCH EMULSION 5 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71656-012-30 71656001230 6 POUCH in 1 CARTON (71656-012-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE 6 pouch 2025-12-12 No No Current 71656-012-60 71656001260 12 POUCH in 1 CARTON (71656-012-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE 12 pouch 2025-12-12 No No Current