Sirolimus

Product NDC: 70518-3795
Requested package NDC: 70518-3795-0
11-digit product format: 705183795
Labeler code: 70518
Product ID: 70518-3795_570c7465-1357-1317-e063-6394a90a046a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sirolimus
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA201578
Marketing category: ANDA
Marketing start: 2023-07-17
Substance: SIROLIMUS
Active strength: 1 mg/1
Pharmacologic classes: Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201578-001	SIROLIMUS	SIROLIMUS	1MG	TABLET / ORAL	AB		2014-10-27
A201578-002	SIROLIMUS	SIROLIMUS	2MG	TABLET / ORAL	AB		2014-10-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A201578-001	AB
A201578-002	AB

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 · 86 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	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201578-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2014-10-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201578-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2014-10-27	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A201578-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201578-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201578-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201578-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201578-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201578-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201578-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201578-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201578-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201578-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201578-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201578-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201578-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201578-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201578-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201578-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201578-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201578-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201578-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201578-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201578-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201578-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201578-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201578-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201578-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201578-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201578-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201578-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201578-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201578-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201578-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201578-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201578-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201578-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201578-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201578-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201578-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201578-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201578-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201578-002	AB	1	`74a2ff9319b5…`

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: Sirolimus
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SIROLIMUS	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
W36ZG6FT64	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349208	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
fc81cb86-61e1-4622-b2ce-cde263143aa0	Available on FDA.report

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sirolimus	SIROLIMUS	REMEDYREPACK INC.	fc81cb86-61e1-4622-b2ce-cde263143aa0	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201578 application number: ANDA201578 ndc (package): 70518-3795-0 ndc (product): 70518-3795 ndc11 (package): 70518379500
Sirolimus	SIROLIMUS	AvPAK	6a85ad01-8144-4d9c-e053-2991aa0a4f85	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201578 application number: ANDA201578
Sirolimus	SIROLIMUS	American Health Packaging	5df60452-2b16-4ce9-8c29-48798a59d718	2025-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201578 application number: ANDA201578
Sirolimus	SIROLIMUS	Dr. Reddy's Laboratories Limited	2e6130e5-fa94-dcf8-605c-817bf396e93d	2023-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201578 application number: ANDA201578

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W36ZG6FT64	SIROLIMUS	53123-88-9	SIROLIMUS

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-3795-0	70518379500	100 POUCH in 1 BOX (70518-3795-0) / 1 TABLET in 1 POUCH (70518-3795-1)	100 pouch	2023-07-17	No	No	Current