Home NDC 68084-879 Cyclosporine
Product NDC 68084-879
11-digit product format 680840879
Labeler code 68084
Product ID 68084-879_1857b1ea-c3f7-696a-e063-6394a90ad6eb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclosporine
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler American Health Packaging
Application ANDA065040
Marketing category ANDA
Marketing start 2015-09-30
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065040-001 CYCLOSPORINE CYCLOSPORINE 25MG CAPSULE / ORAL AB2 2002-05-09 A065040-002 CYCLOSPORINE CYCLOSPORINE 100MG CAPSULE / ORAL AB2 2002-05-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 82 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 A065040-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB2 2002-05-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065040-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB2 2002-05-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065040-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB2 2002-05-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065040-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB2 2002-05-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065040-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB2 2002-05-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065040-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB2 2002-05-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065040-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB2 2002-05-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065040-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB2 2002-05-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065040-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB2 2002-05-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065040-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB2 2002-05-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065040-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB2 2002-05-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065040-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB2 2002-05-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065040-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB2 2002-05-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065040-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB2 2002-05-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065040-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB2 2002-05-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065040-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB2 2002-05-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065040-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB2 2002-05-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065040-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB2 2002-05-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065040-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB2 2002-05-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065040-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB2 2002-05-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065040-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB2 2002-05-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065040-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB2 2002-05-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065040-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB2 2002-05-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065040-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB2 2002-05-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065040-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB2 2002-05-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065040-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB2 2002-05-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065040-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB2 2002-05-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065040-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB2 2002-05-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065040-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB2 2002-05-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065040-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB2 2002-05-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065040-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB2 2002-05-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065040-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB2 2002-05-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065040-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB2 2002-05-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065040-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB2 2002-05-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065040-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB2 2002-05-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065040-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB2 2002-05-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065040-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB2 2002-05-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065040-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB2 2002-05-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065040-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB2 2002-05-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065040-002 CYCLOSPORINE 100MG CAPSULE / ORAL AB2 2002-05-09 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cyclosporine
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197553 Internal RxNorm lookup 328160 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 68084-879-25 Cyclosporine 30 in 1 BOX, UNIT-DOSE CAPSULE, GELATIN COATED 30 8 68084-879-95 Cyclosporine 1 in 1 BLISTER PACK CAPSULE, GELATIN COATED 1 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CYCLOSPORINE ACTIVE INGREDIENT 83HN0GTJ6D CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 3 CYCLOSPORINE ACTIVE MOIETY 83HN0GTJ6D CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 3 ALCOHOL INACTIVE INGREDIENT 3K9958V90M CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 3 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 3 METHYL ALCOHOL INACTIVE INGREDIENT Y4S76JWI15 CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 3 SHELLAC INACTIVE INGREDIENT 46N107B71O CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 3 WATER INACTIVE INGREDIENT 059QF0KO0R CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68084-879 CYCLOSPORINE CAPSULE, GELATIN COATED [AMERICAN HEALTH PACKAGING] 8 Current NDC, Legacy NDC, 2 package rows 20240514_a8e29b54-e4ab-4bb9-ab6c-e4414a3f025b.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 · 2 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 68084-879-25 68084087925 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-879-25) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68084-879-95) 30 blister pack 2015-09-30 0000-00-00 No No Current 68084-879-95 68084087995 1 in 1 BLISTER PACK Historical