SIROLIMUS TABLETS

Manufacturer: Zydus Lifesciences Limited
Effective date: 2023-09-27
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 11
Source: full-release
Hydrated at: 2026-05-31 20:53:30

Label at a glance#

Productsirolimus

Active ingredientSIROLIMUS

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sirolimus Tablets, 0.5 mg

NDC 65841-771-01

100 Tablets

Rx only

Sirolimus Tablets, 1 mg

NDC 65841-772-01

100 Tablets

Rx only

Sirolimus Tablets, 2 mg

NDC 65841-773-01

100 Tablets

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
905158	sirolimus 0.5 MG Oral Tablet	PSN	11
349208	sirolimus 1 MG Oral Tablet	PSN	11
360110	sirolimus 2 MG Oral Tablet	PSN	11
905158	sirolimus 0.5 MG Oral Tablet	SCD	11
349208	sirolimus 1 MG Oral Tablet	SCD	11
360110	sirolimus 2 MG Oral Tablet	SCD	11

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
SIROLIMUS Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

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
65841-771-01	sirolimus	100 in 1 BOTTLE	TABLET, FILM COATED	100	11
65841-771-05	sirolimus	500 in 1 BOTTLE	TABLET, FILM COATED	500	11
65841-771-06	sirolimus	30 in 1 BOTTLE	TABLET, FILM COATED	30	11
65841-771-10	sirolimus	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	11
65841-771-16	sirolimus	90 in 1 BOTTLE	TABLET, FILM COATED	90	11
65841-771-30	sirolimus	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	11
65841-771-77	sirolimus	10 in 1 CARTON	TABLET, FILM COATED	10	11
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
65841-773-01	sirolimus	100 in 1 BOTTLE	TABLET, FILM COATED	100	11
65841-773-30	sirolimus	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	11
65841-773-77	sirolimus	10 in 1 CARTON	TABLET, FILM COATED	10	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-771	SIROLIMUS TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	11	Current NDC, Legacy NDC, 7 package rows	20230928_82562b68-224d-482a-b399-a89b81d5eb31.zip
65841-772	SIROLIMUS TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	11	Current NDC, 3 package rows	20230928_82562b68-224d-482a-b399-a89b81d5eb31.zip
65841-773	SIROLIMUS TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	11	Current NDC, 3 package rows	20230928_82562b68-224d-482a-b399-a89b81d5eb31.zip

DailyMed Socrata Ingredients#

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

sirolimus
ALPHA-TOCOPHEROL ACETATE
CELLULOSE, MICROCRYSTALLINE
CITRIC ACID MONOHYDRATE
CROSPOVIDONE (15 MPA.S AT 5%)
FD&C YELLOW NO. 5
FERRIC OXIDE YELLOW
GLYCERYL OLEATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
POLOXAMER 188
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
SUCROSE
TALC
TITANIUM DIOXIDE
CROSPOVIDONE (120 .MU.M)
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 6000
POVIDONE K30
FERRIC OXIDE RED
POLYETHYLENE GLYCOL 8000

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65841-771	65841-771-01, 65841-771-06, 65841-771-16, 65841-771-05, 65841-771-10, 65841-771-30, 65841-771-77
65841-772	65841-772-01, 65841-772-30, 65841-772-77
65841-773	65841-773-01, 65841-773-30, 65841-773-77

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 48 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SIROLIMUS	W36ZG6FT64	ACTIB
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
CROSPOVIDONE (15 MPA.S AT 5%)	68401960MK	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
GLYCERYL OLEATE	4PC054V79P	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
POLOXAMER 188	LQA7B6G8JG	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POVIDONE	FZ989GH94E	IACT
SUCROSE	C151H8M554	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
SIROLIMUS	W36ZG6FT64	ACTIB
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
CROSPOVIDONE (120 .MU.M)	68401960MK	IACT
GLYCERYL OLEATE	4PC054V79P	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
POLOXAMER 188	LQA7B6G8JG	IACT
POLYETHYLENE GLYCOL 3350	G2M7P15E5P	IACT
POLYETHYLENE GLYCOL 6000	30IQX730WE	IACT
POVIDONE K30	U725QWY32X	IACT
SUCROSE	C151H8M554	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
SIROLIMUS	W36ZG6FT64	ACTIB
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
CROSPOVIDONE (120 .MU.M)	68401960MK	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
GLYCERYL OLEATE	4PC054V79P	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 256 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, FILM COATED / ORAL	1.68 mg		Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, FILM COATED / ORAL		6 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, FILM COATED / ORAL		968 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii+route 48 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, FILM COATED / ORAL		6 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	TABLET / ORAL		3 mg	Exact identifier — unii+route 48 equally ranked IID candidates
POLOXAMER 188	POLOXAMER 188	LQA7B6G8JG	TABLET, FILM COATED / ORAL		3 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, FILM COATED / ORAL	1.68 mg		Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, FILM COATED / ORAL		42 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii+route 48 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, FILM COATED / ORAL		6 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	TABLET / ORAL		3 mg	Exact identifier — unii+route 48 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
POLOXAMER 188	POLOXAMER 188	LQA7B6G8JG	TABLET, FILM COATED / ORAL		3 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, FILM COATED / ORAL		6 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, FILM COATED / ORAL	1.68 mg		Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, FILM COATED / ORAL		42 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	CAPSULE / ORAL	NA		Exact identifier — unii+route 48 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii+route 32 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii+route 32 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, FILM COATED / ORAL		6 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, FILM COATED / ORAL		968 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, FILM COATED / ORAL		968 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii+route 32 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	CAPSULE / ORAL	NA		Exact identifier — unii+route 48 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	CAPSULE / ORAL	NA		Exact identifier — unii+route 48 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	CAPSULE / ORAL	NA		Exact identifier — unii+route 48 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii+route 32 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	TABLET / ORAL		3 mg	Exact identifier — unii+route 48 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii+route 48 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	TABLET / ORAL		3 mg	Exact identifier — unii+route 48 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii+route 32 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, FILM COATED / ORAL	1.68 mg		Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	TABLET / ORAL		3 mg	Exact identifier — unii+route 48 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii+route 48 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii+route 32 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii+route 32 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, FILM COATED / ORAL		42 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, FILM COATED / ORAL		42 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	CAPSULE / ORAL	NA		Exact identifier — unii+route 48 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii+route 48 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, FILM COATED / ORAL		6 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii+route 32 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, FILM COATED / ORAL		42 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	CAPSULE / ORAL	NA		Exact identifier — unii+route 48 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, FILM COATED / ORAL		6 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 96 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
2026-10-15 13:18:30	2026-09	A201676-001	SIROLIMUS	1MG	TABLET / ORAL	AB	2023-02-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201676-002	SIROLIMUS	2MG	TABLET / ORAL	AB	2023-02-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201676-003	SIROLIMUS	0.5MG	TABLET / ORAL	AB	2014-01-08	`c2088c7a36db…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A201676-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201676-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201676-003	AB	1	`c2088c7a36db…`
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…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
sirolimus	SIROLIMUS	Zydus Lifesciences Limited	82562b68-224d-482a-b399-a89b81d5eb31	2023-09-27		Exact identifier ndc (package): 65841-771-30 ndc (package): 65841-772-30 ndc (package): 65841-773-77 ndc (package): 65841-772-77 ndc (package): 65841-772-01 ndc (package): 65841-771-10 ndc (package): 65841-771-05 ndc (package): 65841-773-01 ndc (package): 65841-773-30 ndc (package): 65841-771-06 ndc (package): 65841-771-01 ndc (package): 65841-771-77 ndc (package): 65841-771-16 ndc (product): 65841-773 ndc (product): 65841-771 ndc (product): 65841-772 ndc11 (package): 65841077301 ndc11 (package): 65841077177 ndc11 (package): 65841077106 ndc11 (package): 65841077377 ndc11 (package): 65841077105 ndc11 (package): 65841077277 ndc11 (package): 65841077110 ndc11 (package): 65841077230 ndc11 (package): 65841077201 ndc11 (package): 65841077130 ndc11 (package): 65841077116 ndc11 (package): 65841077101 ndc11 (package): 65841077330 spl id: 7e6e294d-cf29-40e2-91e1-9693fdcd6b6c spl set id: 82562b68-224d-482a-b399-a89b81d5eb31

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.