Cyclosporine

Product NDC: 64380-127
Requested package NDC: 64380-127-02
11-digit product format: 643800127
Labeler code: 64380
Product ID: 64380-127_5a05b6b0-5708-58a0-e063-6394a90a38b1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclosporine
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Strides Pharma Science Limited
Application: ANDA216046
Marketing category: ANDA
Marketing start: 2022-08-16
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 43.

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	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.

Application-product, TE code table
Application-product	TE code
A216046-001	AB1
A216046-002	AB1
A216046-003	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 3 · 87 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A216046-001	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2022-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216046-002	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2022-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216046-003	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2022-08-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216046-001	CYCLOSPORINE	25MG	CAPSULE / ORAL	AB1	2022-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216046-002	CYCLOSPORINE	50MG	CAPSULE / ORAL	AB1	2022-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216046-003	CYCLOSPORINE	100MG	CAPSULE / ORAL	AB1	2022-08-02	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 87 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216046-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216046-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216046-003	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216046-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216046-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216046-003	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216046-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216046-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216046-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216046-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216046-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216046-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216046-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216046-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216046-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216046-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216046-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216046-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216046-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216046-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216046-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216046-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216046-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216046-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216046-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216046-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216046-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216046-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216046-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216046-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216046-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216046-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216046-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216046-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216046-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216046-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216046-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216046-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216046-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216046-001	AB1	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Cyclosporine
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 · 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c36132b2-3ec7-4c43-a25e-75cbdbe3d88d	Available on FDA.report

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
b1c0d609-8b97-06ee-2cd0-5652a4b1d019	Product name	1	20140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64380-127	CYCLOSPORINE CAPSULE, LIQUID FILLED [STRIDES PHARMA SCIENCE LIMITED]	5	Current NDC, Legacy NDC	20240224_c36132b2-3ec7-4c43-a25e-75cbdbe3d88d.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclosporine	CYCLOSPORINE	Strides Pharma Science Limited	c36132b2-3ec7-4c43-a25e-75cbdbe3d88d	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216046 application number: ANDA216046 ndc (package): 64380-127-02 ndc (product): 64380-127 ndc11 (package): 64380012702
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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64380-127-02	64380012702	3 BLISTER PACK in 1 CARTON (64380-127-02) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (64380-127-01)	3 blister pack	2022-08-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyclosporine	Strides Pharma Science Limited \| Onesource Softgels Pte. Ltd.	2026-08-27	HUMAN PRESCRIPTION DRUG LABEL	7