Home NDC 51862-460 Cyclosporine
Product NDC 51862-460
11-digit product format 518620460
Labeler code 51862
Product ID 51862-460_2401a70a-8308-4b1b-b1c8-05b91ec230a2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclosporine
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Mayne Pharma Inc.
Application ANDA065044
Marketing category ANDA
Marketing start 2016-07-18
Marketing end 0000-00-00
Substance CYCLOSPORINE
Active strength 100 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 2022-12-31
Current FDA listing Historical FDA.report record 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 A065044-001 CYCLOSPORINE CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 A065044-002 CYCLOSPORINE CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20
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 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51862-460 CYCLOSPORINE CAPSULE, LIQUID FILLED [MAYNE PHARMA INC.] 10 Legacy NDC 20210918_e7165673-8ab1-4fc8-85e5-a67135af7a7f.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cyclosporine CYCLOSPORINE Dr. Reddy's Laboratories Inc 64ec430a-e930-145c-e766-13fb49b64644 2024-06-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 065044 application number: ANDA065044
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51862-460-47 51862046047 30 BLISTER PACK in 1 BOX (51862-460-47) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (51862-460-01) 30 blister pack 2016-07-18 0000-00-00 No No Current