sirolimus

Product NDC: 0904-7147
Requested package NDC: 0904-7147-07
11-digit product format: 009047147
Labeler code: 0904
Product ID: 0904-7147_a44e8696-c6e2-41eb-9700-fa0313cc6932
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sirolimus
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA208691
Marketing category: ANDA
Marketing start: 2020-10-16
Marketing end: 2022-11-30
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: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0904-7147	0904-7147-07	D	Discontinued by firm		2026-08-17

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 · 12 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…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A208691-001	SIROLIMUS	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16
A208691-002	SIROLIMUS	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16
A208691-003	SIROLIMUS	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A208691-001	AB
A208691-002	AB
A208691-003	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 · 111 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
2026-08-18 06:07:40	2026-07	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208691-002	SIROLIMUS	1MG	TABLET / ORAL	AB	2020-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208691-003	SIROLIMUS	2MG	TABLET / ORAL	AB	2020-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208691-001	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2020-10-16	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208691-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208691-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208691-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208691-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208691-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208691-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208691-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208691-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208691-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208691-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208691-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208691-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208691-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208691-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208691-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208691-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208691-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208691-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208691-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208691-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208691-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208691-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208691-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208691-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208691-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208691-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208691-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208691-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208691-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208691-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208691-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208691-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208691-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208691-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208691-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208691-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208691-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208691-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208691-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208691-001	AB	1	`1e350fbaab3a…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
sirolimus	SIROLIMUS	NORTHSTAR RX LLC	ad39eb60-1fa0-4722-8ba1-523194921c2a	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208691 application number: ANDA208691
sirolimus	SIROLIMUS	Glenmark Pharmaceuticals Inc., USA	57fb4d90-3ccb-4a69-af1e-53be83f7a504	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208691 application number: ANDA208691
sirolimus	SIROLIMUS	REMEDYREPACK INC.	9970e495-29c4-47b8-a3e9-c9b365abe400	2025-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208691 application number: ANDA208691

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	Marketing end	Sample	Exclude flag	Status
0904-7147-07	00904714707	30 BLISTER PACK in 1 CARTON (0904-7147-07) > 1 TABLET, FILM COATED in 1 BLISTER PACK	30 blister pack	2020-10-16	2022-11-30	No	No	Current