sirolimus

Product NDC: 65841-772
11-digit product format: 658410772
Labeler code: 65841
Product ID: 65841-772_7e6e294d-cf29-40e2-91e1-9693fdcd6b6c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sirolimus
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA201676
Marketing category: ANDA
Marketing start: 2023-02-16
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: 2026-12-31
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: 2026-12-31

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349208	Internal RxNorm lookup
360110	Internal RxNorm lookup
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
82562b68-224d-482a-b399-a89b81d5eb31	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e68235d1-1e8b-9d8c-fddb-764b8b692c25	Product name	7	20250331
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9344cc31-0398-4e2f-a65e-a24a0de47fc4	Product name	1	20230103
741e13fe-61d8-4a4c-8c27-eb206b28f1bf	Product name	1	20220613
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65841-772-01	sirolimus	100 in 1 BOTTLE	TABLET, FILM COATED	100	11
65841-772-30	sirolimus	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	11
65841-772-77	sirolimus	10 in 1 CARTON	TABLET, FILM COATED	10	11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SIROLIMUS	ACTIVE INGREDIENT	W36ZG6FT64	SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
SIROLIMUS	ACTIVE MOIETY	W36ZG6FT64	SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
GLYCERYL MONOOLEATE	INACTIVE INGREDIENT	4PC054V79P	SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-772	SIROLIMUS TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	11	Current NDC, 3 package rows	20230928_82562b68-224d-482a-b399-a89b81d5eb31.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 · 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 ndc (product): 65841-772
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
905158	sirolimus 0.5 MG Oral Tablet	PSN	82562b68-224d-482a-b399-a89b81d5eb31	11
349208	sirolimus 1 MG Oral Tablet	PSN	82562b68-224d-482a-b399-a89b81d5eb31	11
360110	sirolimus 2 MG Oral Tablet	PSN	82562b68-224d-482a-b399-a89b81d5eb31	11
905158	sirolimus 0.5 MG Oral Tablet	SCD	82562b68-224d-482a-b399-a89b81d5eb31	11
349208	sirolimus 1 MG Oral Tablet	SCD	82562b68-224d-482a-b399-a89b81d5eb31	11
360110	sirolimus 2 MG Oral Tablet	SCD	82562b68-224d-482a-b399-a89b81d5eb31	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
65841-772-01	65841077201	100 TABLET, FILM COATED in 1 BOTTLE (65841-772-01)		2023-02-16	No	No	Current
65841-772-30	65841077230	10 in 1 BLISTER PACK					Historical
65841-772-77	65841077277	10 BLISTER PACK in 1 CARTON (65841-772-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-772-30)	10 blister pack	2023-02-16	No	No	Current