Home NDC 0078-0274 Neoral
Product NDC 0078-0274
11-digit product format 000780274
Labeler code 0078
Product ID 0078-0274_df11902a-3b90-428d-80f5-d587be982b4c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cyclosporine
Dosage form SOLUTION
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Application NDA050716
Marketing category NDA
Marketing start 1995-07-14
Substance CYCLOSPORINE
Active strength 100 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 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050716-001 NEORAL CYCLOSPORINE 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050716-001 AB1
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 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050716-001 NEORAL 100MG/ML SOLUTION / ORAL AB1 RLD, RS 1995-07-14 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 Neoral
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYCLOSPORINE 100 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 241834 Internal RxNorm lookup 835886 Internal RxNorm lookup 835894 Internal RxNorm lookup 835899 Internal RxNorm lookup 835909 Internal RxNorm lookup 835911 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 0078-0274-22 Neoral 1 in 1 CARTON SOLUTION 1 28 0078-0274-22 Neoral 50 mL in 1 BOTTLE SOLUTION 50 28
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CYCLOSPORINE ACTIVE INGREDIENT 83HN0GTJ6D NEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 15 CYCLOSPORINE ACTIVE MOIETY 83HN0GTJ6D NEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 15 COCHINEAL INACTIVE INGREDIENT TZ8Z31B35M NEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 15 CORN OIL INACTIVE INGREDIENT 8470G57WFM NEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 15 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 NEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 15 GELATIN INACTIVE INGREDIENT 2G86QN327L NEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 15 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 15 POLYOXYL 40 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT 7YC686GQ8F NEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 15 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 15 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 15 TOCOPHEROL INACTIVE INGREDIENT R0ZB2556P8 NEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0274 NEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 26 Current NDC, Legacy NDC, 2 package rows 20240719_94461af3-11f1-4670-95d4-2965b9538ae3.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 Neoral CYCLOSPORINE Novartis Pharmaceuticals Corporation 94461af3-11f1-4670-95d4-2965b9538ae3 2026-07-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 050716 application number: NDA050716 ndc (product): 0078-0274
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 241834 cycloSPORINE, modified 100 MG Oral Capsule PSN 94461af3-11f1-4670-95d4-2965b9538ae3 28 835886 cycloSPORINE, modified 100 MG/mL Oral Solution PSN 94461af3-11f1-4670-95d4-2965b9538ae3 28 835894 cycloSPORINE, modified 25 MG Oral Capsule PSN 94461af3-11f1-4670-95d4-2965b9538ae3 28 835899 NEORAL 100 MG in 1 mL Oral Solution PSN 94461af3-11f1-4670-95d4-2965b9538ae3 28 835911 Neoral 100 MG Oral Capsule PSN 94461af3-11f1-4670-95d4-2965b9538ae3 28 835909 Neoral 25 MG Oral Capsule PSN 94461af3-11f1-4670-95d4-2965b9538ae3 28 835911 cyclosporine, modified 100 MG Oral Capsule [Neoral] SBD 94461af3-11f1-4670-95d4-2965b9538ae3 28 835899 cyclosporine, modified 100 MG/ML Oral Solution [Neoral] SBD 94461af3-11f1-4670-95d4-2965b9538ae3 28 835909 cyclosporine, modified 25 MG Oral Capsule [Neoral] SBD 94461af3-11f1-4670-95d4-2965b9538ae3 28 241834 cyclosporine, modified 100 MG Oral Capsule SCD 94461af3-11f1-4670-95d4-2965b9538ae3 28 835886 cyclosporine, modified 100 MG/ML Oral Solution SCD 94461af3-11f1-4670-95d4-2965b9538ae3 28 835894 cyclosporine, modified 25 MG Oral Capsule SCD 94461af3-11f1-4670-95d4-2965b9538ae3 28 835911 Neoral 100 MG Oral Capsule SY 94461af3-11f1-4670-95d4-2965b9538ae3 28 835899 Neoral 100 MG per 1 ML Oral Solution SY 94461af3-11f1-4670-95d4-2965b9538ae3 28 835909 Neoral 25 MG Oral Capsule SY 94461af3-11f1-4670-95d4-2965b9538ae3 28
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0078-0274-22 00078027422 1 BOTTLE in 1 CARTON (0078-0274-22) / 50 mL in 1 BOTTLE 1 bottle 1995-07-14 0000-00-00 No No Current