Sirolimus

Product NDC: 68084-956
11-digit product format: 680840956
Labeler code: 68084
Product ID: 68084-956_89030640-5556-aba7-e053-2995a90ab773
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sirolimus
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: American Health Packaging
Application: ANDA201676
Marketing category: ANDA
Marketing start: 2015-03-31
Marketing end: 2020-04-30
Substance: SIROLIMUS
Active strength: 1 mg/1
Pharmacologic classes: Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68084-956		D	Discontinued by firm	2026-08-17
excluded package	package	68084-956	68084-956-21	D	Discontinued by firm	2026-08-17
excluded package	package	68084-956	68084-956-25	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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68084-956-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68084-956-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68084-956-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68084-956-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68084-956-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68084-956-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68084-956-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68084-956-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68084-956-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68084-956-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68084-956-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68084-956-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68084-956-25	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68084-956-21	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68084-956-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68084-956-21	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68084-956-25	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68084-956-21	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68084-956-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68084-956-21	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68084-956-25	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68084-956-21	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68084-956-25	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68084-956-21	`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
A201676-001	SIROLIMUS	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15
A201676-002	SIROLIMUS	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15
A201676-003	SIROLIMUS	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201676-001	AB
A201676-002	AB
A201676-003	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 · 90 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	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 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	A201676-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201676-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201676-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201676-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201676-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201676-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201676-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201676-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201676-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201676-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201676-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201676-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201676-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201676-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201676-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201676-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201676-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201676-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201676-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201676-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201676-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201676-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201676-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201676-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201676-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201676-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201676-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201676-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201676-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201676-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201676-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201676-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201676-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201676-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201676-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201676-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201676-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201676-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201676-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201676-001	AB	1	`1e350fbaab3a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-956-25	EA - Each	68084-956	902e7a51-75f8-4e64-8ee9-e18e0e1d0112	1	2015-12-02
68084-956-95	EA - Each	68084-956	8cc52c8a-16f4-4dfc-bbd6-15f16838c9d0	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SIROLIMUS	ACTIVE INGREDIENT	W36ZG6FT64	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
SIROLIMUS	ACTIVE MOIETY	W36ZG6FT64	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
GLYCERYL OLEATE	INACTIVE INGREDIENT	4PC054V79P	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3

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	American Health Packaging	a71c205f-7acc-40e5-9eee-69daeb49a352	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201676 application number: ANDA201676
sirolimus	SIROLIMUS	REMEDYREPACK INC.	09f24e7a-0bea-4e02-b557-c60eb842d41a	2025-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201676 application number: ANDA201676
sirolimus	SIROLIMUS	Zydus Lifesciences Limited	82562b68-224d-482a-b399-a89b81d5eb31	2023-09-27		Exact identifier application applno (ANDA): 201676 application number: ANDA201676
sirolimus	SIROLIMUS	Zydus Pharmaceuticals USA Inc.	ec473170-47f1-4a5c-b4d9-ac36406ed241	2023-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201676 application number: ANDA201676