Home NDC 0093-5740-65 Cyclosporine
Product NDC 0093-5740
Requested package NDC 0093-5740-65
11-digit product format 000935740
Labeler code 0093
Product ID 0093-5740_0d006301-5ba4-46a1-a767-fbaa2a94bb75
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclosporine
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA065110
Marketing category ANDA
Marketing start 2015-06-01
Marketing end 2022-12-31
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 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A065110-001 CYCLOSPORINE CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2005-03-29 A065110-002 CYCLOSPORINE CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2005-03-29 A065110-003 CYCLOSPORINE CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2005-03-29
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.
Product history page 1 of 4 · 123 observed 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 A065110-001 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2005-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065110-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2005-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065110-003 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2005-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065110-001 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2005-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065110-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2005-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065110-003 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2005-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065110-001 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2005-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065110-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2005-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065110-003 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2005-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065110-001 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2005-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065110-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2005-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065110-003 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2005-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065110-001 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2005-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065110-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2005-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065110-003 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2005-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065110-001 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2005-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065110-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2005-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065110-003 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2005-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065110-001 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2005-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065110-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2005-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065110-003 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2005-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065110-001 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2005-03-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065110-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2005-03-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065110-003 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2005-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065110-001 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2005-03-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065110-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2005-03-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065110-003 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2005-03-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065110-001 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2005-03-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065110-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2005-03-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065110-003 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2005-03-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065110-001 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2005-03-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065110-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2005-03-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065110-003 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2005-03-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065110-001 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2005-03-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065110-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2005-03-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065110-003 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2005-03-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065110-001 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2005-03-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065110-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2005-03-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065110-003 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2005-03-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065110-001 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2005-03-29 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0093-5740-65 00093574065 30 BLISTER PACK in 1 CARTON (0093-5740-65) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0093-5740-19) 30 blister pack 2015-06-01 2022-12-31 No No Current