Home NDC 0378-8760 Cyclosporine
Product NDC 0378-8760
11-digit product format 003788760
Labeler code 0378
Product ID 0378-8760_da3fa070-b512-4568-871a-dc8d5a949d13
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cyclosporine
Dosage form EMULSION
Route OPHTHALMIC
Labeler Mylan Pharmaceuticals Inc.
Application ANDA205894
Marketing category ANDA
Marketing start 2022-02-03
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 A205894-001 CYCLOSPORINE CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205894-001 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 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205894-001 CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB 2022-02-02 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 0378-8760-58 Cyclosporine 6 in 1 CARTON EMULSION 6 1 0378-8760-91 Cyclosporine 5 in 1 POUCH EMULSION 5 1 0378-8760-91 Cyclosporine 12 in 1 CARTON EMULSION 12 1 0378-8760-98 Cyclosporine 5 in 1 POUCH EMULSION 5 1 0378-8760-98 Cyclosporine 0.4 mL in 1 VIAL, SINGLE-USE EMULSION 0.4 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-8760 CYCLOSPORINE EMULSION [MYLAN PHARMACEUTICALS INC.] 1 Current NDC, Legacy NDC, 5 package rows 20220205_da3fa070-b512-4568-871a-dc8d5a949d13.zip
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 Marketing end Sample Exclude flag Status 0378-8760-58 00378876058 6 POUCH in 1 CARTON (0378-8760-58) / 5 VIAL, SINGLE-USE in 1 POUCH (0378-8760-98) / .4 mL in 1 VIAL, SINGLE-USE 6 pouch 2022-02-03 0000-00-00 No No Current 0378-8760-91 00378876091 12 POUCH in 1 CARTON (0378-8760-91) / 5 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE 12 pouch 2022-02-03 0000-00-00 No No Current 0378-8760-98 00378876098 5 in 1 POUCH Historical