Home NDC 0093-9018 Cyclosporine
Product NDC 0093-9018
11-digit product format 000939018
Labeler code 0093
Product ID 0093-9018_d5d977b4-fc80-4e46-ab55-280fd6d4ea12
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 2021-06-08
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 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 · 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.
Additional Listing Data#
Finished product Yes
Brand name base Cyclosporine
Brand name suffix Modified
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYCLOSPORINE 25 mg/1
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 241834 Internal RxNorm lookup 835894 Internal RxNorm lookup 835925 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 0093-9018-19 CyclosporineModified 1 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 1 10 0093-9018-65 CyclosporineModified 30 in 1 CARTON CAPSULE, LIQUID FILLED 30 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CYCLOSPORINE ACTIVE INGREDIENT 83HN0GTJ6D CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] 2 CYCLOSPORINE ACTIVE MOIETY 83HN0GTJ6D CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] 2 .ALPHA.-TOCOPHEROL, DL- INACTIVE INGREDIENT 7QWA1RIO01 CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] 2 BROWN IRON OXIDE INACTIVE INGREDIENT 1N032N7MFO CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] 2 GLYCINE INACTIVE INGREDIENT TE7660XO1C CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] 2 POLYGLYCERYL-10 OLEATE INACTIVE INGREDIENT 55C81W76DH CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] 2 POLYGLYCERYL-3 OLEATE INACTIVE INGREDIENT XRQ165498B CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] 2 POLYOXYL 40 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT 7YC686GQ8F CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-9018 CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20250227_2de1e8b1-625f-43ce-a1d5-d543be208b11.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 0093-9018-19 00093901819 1 in 1 BLISTER PACK Historical 0093-9018-65 00093901865 30 BLISTER PACK in 1 CARTON (0093-9018-65) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0093-9018-19) 30 blister pack 2021-06-08 0000-00-00 No No Current