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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0093-57400093-5740-65DDiscontinued by firm2026-08-11

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065110-001CYCLOSPORINECYCLOSPORINE50MGCAPSULE / ORALAB12005-03-29
A065110-002CYCLOSPORINECYCLOSPORINE100MGCAPSULE / ORALAB12005-03-29
A065110-003CYCLOSPORINECYCLOSPORINE25MGCAPSULE / ORALAB12005-03-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A065110-001AB1
A065110-002AB1
A065110-003AB1

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065110-001CYCLOSPORINE50MGCAPSULE / ORALAB12005-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065110-002CYCLOSPORINE100MGCAPSULE / ORALAB12005-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065110-003CYCLOSPORINE25MGCAPSULE / ORALAB12005-03-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065110-001CYCLOSPORINE50MGCAPSULE / ORALAB12005-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065110-002CYCLOSPORINE100MGCAPSULE / ORALAB12005-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065110-003CYCLOSPORINE25MGCAPSULE / ORALAB12005-03-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A065110-001CYCLOSPORINE50MGCAPSULE / ORALAB12005-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065110-002CYCLOSPORINE100MGCAPSULE / ORALAB12005-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065110-003CYCLOSPORINE25MGCAPSULE / ORALAB12005-03-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065110-001CYCLOSPORINE50MGCAPSULE / ORALAB12005-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065110-002CYCLOSPORINE100MGCAPSULE / ORALAB12005-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065110-003CYCLOSPORINE25MGCAPSULE / ORALAB12005-03-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065110-001CYCLOSPORINE50MGCAPSULE / ORALAB12005-03-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065110-002CYCLOSPORINE100MGCAPSULE / ORALAB12005-03-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065110-003CYCLOSPORINE25MGCAPSULE / ORALAB12005-03-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065110-001CYCLOSPORINE50MGCAPSULE / ORALAB12005-03-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065110-002CYCLOSPORINE100MGCAPSULE / ORALAB12005-03-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065110-003CYCLOSPORINE25MGCAPSULE / ORALAB12005-03-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065110-001CYCLOSPORINE50MGCAPSULE / ORALAB12005-03-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065110-002CYCLOSPORINE100MGCAPSULE / ORALAB12005-03-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065110-003CYCLOSPORINE25MGCAPSULE / ORALAB12005-03-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065110-001CYCLOSPORINE50MGCAPSULE / ORALAB12005-03-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065110-002CYCLOSPORINE100MGCAPSULE / ORALAB12005-03-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065110-003CYCLOSPORINE25MGCAPSULE / ORALAB12005-03-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065110-001CYCLOSPORINE50MGCAPSULE / ORALAB12005-03-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065110-002CYCLOSPORINE100MGCAPSULE / ORALAB12005-03-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065110-003CYCLOSPORINE25MGCAPSULE / ORALAB12005-03-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065110-001CYCLOSPORINE50MGCAPSULE / ORALAB12005-03-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A065110-002CYCLOSPORINE100MGCAPSULE / ORALAB12005-03-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A065110-003CYCLOSPORINE25MGCAPSULE / ORALAB12005-03-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065110-001CYCLOSPORINE50MGCAPSULE / ORALAB12005-03-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065110-002CYCLOSPORINE100MGCAPSULE / ORALAB12005-03-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065110-003CYCLOSPORINE25MGCAPSULE / ORALAB12005-03-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065110-001CYCLOSPORINE50MGCAPSULE / ORALAB12005-03-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065110-002CYCLOSPORINE100MGCAPSULE / ORALAB12005-03-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065110-003CYCLOSPORINE25MGCAPSULE / ORALAB12005-03-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065110-001CYCLOSPORINE50MGCAPSULE / ORALAB12005-03-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065110-002CYCLOSPORINE100MGCAPSULE / ORALAB12005-03-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065110-003CYCLOSPORINE25MGCAPSULE / ORALAB12005-03-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065110-001CYCLOSPORINE50MGCAPSULE / ORALAB12005-03-298072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065110-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065110-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065110-003AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065110-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065110-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065110-003AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065110-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065110-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065110-003AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065110-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065110-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065110-003AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065110-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065110-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065110-003AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065110-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065110-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065110-003AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065110-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065110-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065110-003AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065110-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065110-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065110-003AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065110-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065110-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065110-003AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065110-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A065110-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A065110-003AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065110-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065110-002AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065110-003AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065110-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065110-002AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065110-003AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065110-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065110-002AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065110-003AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065110-001AB118072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5740-19EA - Each0093-574099511f5c-fb3f-4c18-87c0-0951e1f9d47412015-08-04
0093-5740-65EA - Each0093-574085079ce1-e3a1-4f11-b186-ee94d3cf532012015-08-04

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyclosporine ModifiedCYCLOSPORINETeva Pharmaceuticals USA, Inc.2de1e8b1-625f-43ce-a1d5-d543be208b112024-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065110
application number: ANDA065110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-5740-650009357406530 BLISTER PACK in 1 CARTON (0093-5740-65) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0093-5740-19) 30 blister pack2015-06-012022-12-31NoNoCurrent