Home NDC 0078-0240 Sandimmune
Product NDC 0078-0240
11-digit product format 000780240
Labeler code 0078
Product ID 0078-0240_fa1f5eda-922e-49c8-a618-2967b00d1ac0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cyclosporine
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Application NDA050625
Marketing category NDA
Marketing start 1990-03-02
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 2027-12-31
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 N050625-001 SANDIMMUNE CYCLOSPORINE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 N050625-002 SANDIMMUNE CYCLOSPORINE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 N050625-003 SANDIMMUNE CYCLOSPORINE 50MG CAPSULE / ORAL BX RLD 1992-11-23
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 4 · 123 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 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050625-002 SANDIMMUNE 100MG CAPSULE / ORAL AB2 RLD, RS 1990-03-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050625-003 SANDIMMUNE 50MG CAPSULE / ORAL BX RLD 1992-11-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050625-001 SANDIMMUNE 25MG CAPSULE / ORAL AB2 RLD 1990-03-02 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sandimmune
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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197552 Internal RxNorm lookup 197553 Internal RxNorm lookup 205175 Internal RxNorm lookup 212810 Internal RxNorm lookup 212844 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 0078-0240-15 Sandimmune 30 in 1 PACKAGE CAPSULE, LIQUID FILLED 30 36 0078-0240-61 Sandimmune 1 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 1 36
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CYCLOSPORINE ACTIVE INGREDIENT 83HN0GTJ6D SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 17 CYCLOSPORINE ACTIVE MOIETY 83HN0GTJ6D SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 17 ALCOHOL INACTIVE INGREDIENT 3K9958V90M SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 17 CASTOR OIL INACTIVE INGREDIENT D5340Y2I9G SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 17 CORN OIL INACTIVE INGREDIENT 8470G57WFM SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 17 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 17 GELATIN INACTIVE INGREDIENT 2G86QN327L SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 17 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 17 NITROGEN INACTIVE INGREDIENT N762921K75 SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 17 OLIVE OIL INACTIVE INGREDIENT 6UYK2W1W1E SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 17 SORBITOL INACTIVE INGREDIENT 506T60A25R SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 17 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0240 SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 32 Current NDC, Legacy NDC, 2 package rows 20250122_5e5926a7-1de0-4b54-a5c0-286b6200ff82.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 Sandimmune CYCLOSPORINE Novartis Pharmaceuticals Corporation 5e5926a7-1de0-4b54-a5c0-286b6200ff82 2026-07-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 050625 application number: NDA050625 ndc (product): 0078-0240
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 0078-0240-15 00078024015 30 BLISTER PACK in 1 PACKAGE (0078-0240-15) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0240-61) 30 blister pack 1990-03-02 0000-00-00 No No Current 0078-0240-61 00078024061 1 in 1 BLISTER PACK Historical