Yulithira

Product NDC: 82249-612
11-digit product format: 822490612
Labeler code: 82249
Product ID: 82249-612_01d9a611-3216-427b-a18a-15366572b3d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Everolimus
Dosage form: TABLET
Route: ORAL
Labeler: CivicaScript, LLC
Application: ANDA205426
Marketing category: ANDA
Marketing start: 2021-03-05
Substance: EVEROLIMUS
Active strength: 7.5 mg/1
Pharmacologic classes: Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205426-001	EVEROLIMUS	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-03-05
A205426-002	EVEROLIMUS	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-03-05
A205426-003	EVEROLIMUS	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-03-05
A205426-004	EVEROLIMUS	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-03-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A205426-001	AB
A205426-002	AB
A205426-003	AB
A205426-004	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 4 · 144 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	A205426-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205426-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205426-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205426-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-03-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205426-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-03-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205426-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-03-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205426-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-03-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205426-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-03-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205426-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205426-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205426-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205426-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-03-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205426-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-03-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205426-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-03-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205426-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-03-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205426-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-03-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205426-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-03-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205426-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-03-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205426-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-03-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205426-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-03-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205426-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-03-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205426-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-03-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205426-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-03-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205426-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-03-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205426-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-03-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205426-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-03-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205426-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-03-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205426-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-03-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205426-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-03-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205426-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-03-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205426-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-03-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205426-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-03-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205426-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-03-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205426-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-03-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205426-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-03-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205426-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-03-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205426-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-03-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205426-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-03-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205426-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-03-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205426-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-03-05	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 144 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	A205426-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205426-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205426-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205426-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205426-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205426-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205426-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205426-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205426-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205426-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205426-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205426-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205426-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205426-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205426-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205426-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205426-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205426-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205426-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205426-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205426-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205426-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205426-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205426-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205426-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205426-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205426-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205426-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205426-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205426-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205426-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205426-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205426-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205426-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205426-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205426-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205426-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205426-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205426-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205426-004	AB	1	`5bbf6a4d5a75…`

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: Yulithira
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EVEROLIMUS	7.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9HW64Q8G6G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
845507	Internal RxNorm lookup
845515	Internal RxNorm lookup
998189	Internal RxNorm lookup
1119400	Internal RxNorm lookup
2745127	Internal RxNorm lookup
2745129	Internal RxNorm lookup
2745131	Internal RxNorm lookup
2745133	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
5e325efa-8ae6-4dac-b59b-d7c74c73186c	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Yulithira	EVEROLIMUS	CivicaScript, LLC	5e325efa-8ae6-4dac-b59b-d7c74c73186c	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205426 application number: ANDA205426 ndc (product): 82249-612
Everolimus	EVEROLIMUS	Breckenridge Pharmaceutical, Inc.	01f7b5fb-be0d-4adf-acd2-6899018de966	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205426 application number: ANDA205426
Everolimus	EVEROLIMUS	Natco Pharma Limited	e3dbbc24-7e55-4069-a305-e2cded2db641	2023-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205426 application number: ANDA205426

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9HW64Q8G6G	EVEROLIMUS	159351-69-6	EVEROLIMUS

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82249-612-30	82249061230	30 TABLET in 1 BOTTLE (82249-612-30)	30 tablet	2026-06-11	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Yulithira	CivicaScript, LLC \| Natco Pharma Ltd \| Natco Pharma Ltd.	2026-03-31	HUMAN PRESCRIPTION DRUG LABEL	2