Home NDC 0078-0109 Sandimmune
Product NDC 0078-0109
11-digit product format 000780109
Labeler code 0078
Product ID 0078-0109_fa1f5eda-922e-49c8-a618-2967b00d1ac0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cyclosporine
Dosage form INJECTION
Route INTRAVENOUS
Labeler Novartis Pharmaceuticals Corporation
Application NDA050573
Marketing category NDA
Marketing start 1983-11-14
Substance CYCLOSPORINE
Active strength 50 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050573-001 SANDIMMUNE CYCLOSPORINE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050573-001 AP
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 2 · 41 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 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050573-001 SANDIMMUNE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1983-11-14 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 50 mg/mL
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 0078-0109-01 Sandimmune 10 in 1 BOX INJECTION 10 36 0078-0109-61 Sandimmune 5 mL in 1 AMPULE INJECTION 5 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 0078-0109 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): 050573 application number: NDA050573 ndc (product): 0078-0109
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 0078-0109-01 00078010901 10 AMPULE in 1 BOX (0078-0109-01) / 5 mL in 1 AMPULE (0078-0109-61) 10 ampule 1983-11-14 0000-00-00 No No Current 0078-0109-61 00078010961 5 mL in 1 AMPULE 5 ml Historical