sirolimus

Product NDC: 60687-902
Requested package NDC: 60687-902-21
11-digit product format: 606870902
Labeler code: 60687
Product ID: 60687-902_535ad442-b012-9fcc-e063-6394a90a2857
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: 2026-06-02
Substance: SIROLIMUS
Active strength: .5 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

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
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 · 93 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	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 93 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	A201676-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201676-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201676-003	AB	1	`84e616aacf4f…`
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…`

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	.5 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
905158	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
a71c205f-7acc-40e5-9eee-69daeb49a352	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	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 ndc (package): 60687-902-21 ndc (product): 60687-902 ndc11 (package): 60687090221
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

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
60687-902-21	60687090221	30 BLISTER PACK in 1 CARTON (60687-902-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-902-11)	30 blister pack	2026-06-02	No	No	Current