Home NDC 64380-127 Cyclosporine
Product NDC 64380-127
11-digit product format 643800127
Labeler code 64380
Product ID 64380-127_f42ec7ac-b9f1-4097-ab63-9edda82f5fff
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclosporine
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA216046
Marketing category ANDA
Marketing start 2022-08-16
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A216046-001 CYCLOSPORINE CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2022-08-02 A216046-002 CYCLOSPORINE CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2022-08-02 A216046-003 CYCLOSPORINE CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2022-08-02
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 3 · 87 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 2026-09-14 22:38:34 2026-08 A216046-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2022-08-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216046-002 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2022-08-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216046-003 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2022-08-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216046-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2022-08-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216046-002 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2022-08-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216046-003 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2022-08-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216046-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2022-08-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216046-002 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2022-08-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216046-003 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2022-08-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216046-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2022-08-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216046-002 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2022-08-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216046-003 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2022-08-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216046-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2022-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216046-002 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2022-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216046-003 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2022-08-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216046-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2022-08-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216046-002 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2022-08-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216046-003 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2022-08-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216046-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2022-08-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216046-002 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2022-08-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216046-003 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2022-08-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216046-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2022-08-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216046-002 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2022-08-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216046-003 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2022-08-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216046-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2022-08-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216046-002 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2022-08-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216046-003 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2022-08-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216046-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2022-08-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216046-002 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2022-08-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216046-003 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2022-08-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216046-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2022-08-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216046-002 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2022-08-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216046-003 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2022-08-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216046-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2022-08-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216046-002 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2022-08-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216046-003 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2022-08-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216046-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2022-08-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216046-002 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2022-08-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216046-003 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2022-08-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216046-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2022-08-02 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 87 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cyclosporine
Listing expiration 2027-12-31 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 Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-127 CYCLOSPORINE CAPSULE, LIQUID FILLED [STRIDES PHARMA SCIENCE LIMITED] 5 Legacy NDC 20240224_c36132b2-3ec7-4c43-a25e-75cbdbe3d88d.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64380-127-02 64380012702 3 BLISTER PACK in 1 CARTON (64380-127-02) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (64380-127-01) 3 blister pack 2022-08-16 0000-00-00 No No Current