Sandimmune

Product NDC: 0078-0110
11-digit product format: 000780110
Labeler code: 0078
Product ID: 0078-0110_f37a7aa9-53ff-43e1-b41d-3881b80ea1e9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cyclosporine
Dosage form: SOLUTION
Route: ORAL
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA050574
Marketing category: NDA
Marketing start: 1983-11-14
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0078-0110		D	Discontinued by firm		2026-08-11
excluded package	package	0078-0110	0078-0110-22	D	Discontinued by firm		2026-08-11

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
N050574-001	SANDIMMUNE	CYCLOSPORINE	100MG/ML	SOLUTION / ORAL		RLD, RS	1983-11-14

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	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL		RLD, RS	1983-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL		RLD, RS	1983-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL		RLD, RS	1983-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL		RLD, RS	1983-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL		RLD, RS	1983-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL		RLD, RS	1983-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL		RLD, RS	1983-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL		RLD, RS	1983-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL		RLD, RS	1983-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL		RLD, RS	1983-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL		RLD, RS	1983-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL		RLD, RS	1983-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL		RLD, RS	1983-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL		RLD, RS	1983-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL	AB2	RLD, RS	1983-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL	AB2	RLD, RS	1983-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL	AB2	RLD, RS	1983-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL	AB2	RLD, RS	1983-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL	AB2	RLD, RS	1983-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL	AB2	RLD, RS	1983-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL	AB2	RLD, RS	1983-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL	AB2	RLD, RS	1983-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL	AB2	RLD, RS	1983-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL	AB2	RLD, RS	1983-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL	AB2	RLD, RS	1983-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL	AB2	RLD, RS	1983-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL	AB2	RLD, RS	1983-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL		RLD, RS	1983-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL		RLD, RS	1983-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL		RLD, RS	1983-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL		RLD, RS	1983-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL		RLD, RS	1983-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL	AB2	RLD, RS	1983-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL	AB2	RLD, RS	1983-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL	AB2	RLD, RS	1983-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL	AB2	RLD, RS	1983-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL	AB2	RLD, RS	1983-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL	AB2	RLD, RS	1983-11-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL	AB2	RLD, RS	1983-11-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050574-001	SANDIMMUNE	100MG/ML	SOLUTION / ORAL	AB2	RLD, RS	1983-11-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050574-001	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050574-001	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050574-001	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050574-001	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050574-001	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050574-001	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050574-001	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050574-001	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050574-001	AB2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050574-001	AB2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050574-001	AB2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050574-001	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050574-001	AB2	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050574-001	AB2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050574-001	AB2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050574-001	AB2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050574-001	AB2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050574-001	AB2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050574-001	AB2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050574-001	AB2	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050574-001	AB2	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1be408a0-e15a-4092-b35e-4e294e65196f	Product name	3	20240216
b3fdee3e-0c46-442f-aad5-aa71941d5621	Product name	1	20231023
78fb0708-fce5-decd-6611-5a9fbe3e3dec	Product name	3	20230327
54840517-000d-4fcb-b976-a6ddd102faa0	Product name	1	20220120
a5ba3bd0-8411-4005-ac3b-a41d8ee0633a	Product name	1	20181029
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
b1c0d609-8b97-06ee-2cd0-5652a4b1d019	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0110-22	ML - Milliliter	0078-0110	c03f463d-5fec-4f81-a86b-1cac12540b04	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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
0078-0110	SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]	32	Legacy NDC	20250122_5e5926a7-1de0-4b54-a5c0-286b6200ff82.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
83HN0GTJ6D	CYCLOSPORINE	59865-13-3	CYCLOSPORINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
328160	cycloSPORINE 100 MG Oral Capsule	PSN	5e5926a7-1de0-4b54-a5c0-286b6200ff82	36
197553	cycloSPORINE 25 MG Oral Capsule	PSN	5e5926a7-1de0-4b54-a5c0-286b6200ff82	36
205175	cycloSPORINE 250 MG in 5 ML Injection	PSN	5e5926a7-1de0-4b54-a5c0-286b6200ff82	36
197552	SandIMMUNE 100 MG Oral Capsule	PSN	5e5926a7-1de0-4b54-a5c0-286b6200ff82	36
212810	SandIMMUNE 25 MG Oral Capsule	PSN	5e5926a7-1de0-4b54-a5c0-286b6200ff82	36
212844	SandIMMUNE 250 MG in 5 ML Injection	PSN	5e5926a7-1de0-4b54-a5c0-286b6200ff82	36
212844	5 ML cyclosporine 50 MG/ML Injection [Sandimmune]	SBD	5e5926a7-1de0-4b54-a5c0-286b6200ff82	36
197552	cyclosporine 100 MG Oral Capsule [Sandimmune]	SBD	5e5926a7-1de0-4b54-a5c0-286b6200ff82	36
212810	cyclosporine 25 MG Oral Capsule [Sandimmune]	SBD	5e5926a7-1de0-4b54-a5c0-286b6200ff82	36
205175	5 ML cyclosporine 50 MG/ML Injection	SCD	5e5926a7-1de0-4b54-a5c0-286b6200ff82	36
328160	cyclosporine 100 MG Oral Capsule	SCD	5e5926a7-1de0-4b54-a5c0-286b6200ff82	36
197553	cyclosporine 25 MG Oral Capsule	SCD	5e5926a7-1de0-4b54-a5c0-286b6200ff82	36
212844	5 ML Sandimmune 50 MG/ML Injection	SY	5e5926a7-1de0-4b54-a5c0-286b6200ff82	36
205175	cyclosporine 250 MG per 5 ML Injection	SY	5e5926a7-1de0-4b54-a5c0-286b6200ff82	36
197552	Sandimmune 100 MG Oral Capsule	SY	5e5926a7-1de0-4b54-a5c0-286b6200ff82	36
212810	Sandimmune 25 MG Oral Capsule	SY	5e5926a7-1de0-4b54-a5c0-286b6200ff82	36
212844	Sandimmune 250 MG per 5 ML Injection	SY	5e5926a7-1de0-4b54-a5c0-286b6200ff82	36

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0110-22	00078011022	50 mL in 1 BOTTLE (0078-0110-22)	50 ml	1983-11-14	0000-00-00	No	No	Current