Home NDC 23155-839 CYCLOSPORINE
Product NDC 23155-839
11-digit product format 231550839
Labeler code 23155
Product ID 23155-839_15185077-eec3-40ca-a492-f500a05a045b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CYCLOSPORINE
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application ANDA216046
Marketing category ANDA
Marketing start 2022-11-30
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 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 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 · 81 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 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…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216046-002 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2022-08-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216046-003 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2022-08-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216046-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2022-08-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216046-002 CYCLOSPORINE 50MG CAPSULE / ORAL AB1 2022-08-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216046-003 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2022-08-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216046-001 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2022-08-02 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 81 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 100 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 23155-839-11 CYCLOSPORINE 6 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 6 5 23155-839-30 CYCLOSPORINE 5 in 1 CARTON CAPSULE, LIQUID FILLED 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 23155-839 CYCLOSPORINE CAPSULE, LIQUID FILLED [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] 4 Current NDC, Legacy NDC, 2 package rows 20240322_1952d4c7-a40e-4924-b669-c41400774cb9.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 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 1952d4c7-a40e-4924-b669-c41400774cb9 2025-12-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216046 application number: ANDA216046 ndc (product): 23155-839
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 23155-839-11 23155083911 6 in 1 BLISTER PACK Historical 23155-839-30 23155083930 5 BLISTER PACK in 1 CARTON (23155-839-30) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (23155-839-11) 5 blister pack 2022-11-30 0000-00-00 No No Current