Everolimus

Product NDC: 49884-119
11-digit product format: 498840119
Labeler code: 49884
Product ID: 49884-119_131a5a57-ee0b-4ee9-9c61-9be3dcdcbb25
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Everolimus
Dosage form: TABLET
Route: ORAL
Labeler: Par Pharmaceutical, Inc.
Application: ANDA207934
Marketing category: ANDA
Marketing start: 2019-12-10
Marketing end: 0000-00-00
Substance: EVEROLIMUS
Active strength: 3 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: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	49884-119		D	Discontinued by firm		2026-10-20
excluded package	package	49884-119	49884-119-91	D	Discontinued by firm		2026-10-20

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	49884-119		I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	49884-119	49884-119-91	I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`

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

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	Approval date
A207934-001	EVEROLIMUS	EVEROLIMUS	2.5MG	TABLET / ORAL	2019-12-09
A207934-002	EVEROLIMUS	EVEROLIMUS	5MG	TABLET / ORAL	2019-12-09
A207934-003	EVEROLIMUS	EVEROLIMUS	7.5MG	TABLET / ORAL	2019-12-09
A207934-004	EVEROLIMUS	EVEROLIMUS	10MG	TABLET / ORAL	2020-12-09

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 5 · 162 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	A207934-001	EVEROLIMUS	2.5MG	TABLET / ORAL		2019-12-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207934-002	EVEROLIMUS	5MG	TABLET / ORAL		2019-12-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207934-003	EVEROLIMUS	7.5MG	TABLET / ORAL		2019-12-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207934-004	EVEROLIMUS	10MG	TABLET / ORAL		2020-12-09	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207934-001	EVEROLIMUS	2.5MG	TABLET / ORAL		2019-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207934-002	EVEROLIMUS	5MG	TABLET / ORAL		2019-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207934-003	EVEROLIMUS	7.5MG	TABLET / ORAL		2019-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207934-004	EVEROLIMUS	10MG	TABLET / ORAL		2020-12-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207934-001	EVEROLIMUS	2.5MG	TABLET / ORAL		2019-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207934-002	EVEROLIMUS	5MG	TABLET / ORAL		2019-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207934-003	EVEROLIMUS	7.5MG	TABLET / ORAL		2019-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207934-004	EVEROLIMUS	10MG	TABLET / ORAL		2020-12-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207934-001	EVEROLIMUS	2.5MG	TABLET / ORAL		2019-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207934-002	EVEROLIMUS	5MG	TABLET / ORAL		2019-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207934-003	EVEROLIMUS	7.5MG	TABLET / ORAL		2019-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207934-004	EVEROLIMUS	10MG	TABLET / ORAL		2020-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207934-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2019-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207934-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2019-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207934-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2019-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207934-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2020-12-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207934-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2019-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207934-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2019-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207934-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2019-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207934-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2020-12-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207934-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2019-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207934-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2019-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207934-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2019-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207934-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2020-12-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207934-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2019-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207934-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2019-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207934-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2019-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207934-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2020-12-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207934-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2019-12-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207934-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2019-12-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207934-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2019-12-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207934-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2020-12-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207934-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2019-12-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207934-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2019-12-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207934-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2019-12-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207934-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2020-12-09	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 142 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207934-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207934-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207934-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207934-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207934-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207934-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207934-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207934-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207934-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207934-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207934-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207934-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207934-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207934-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207934-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207934-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207934-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207934-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207934-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207934-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207934-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207934-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207934-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207934-004	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207934-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207934-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207934-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207934-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207934-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207934-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207934-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207934-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207934-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207934-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207934-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207934-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207934-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207934-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207934-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207934-004	AB	1	`5aa47cf7b7d7…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
807eb842-6749-6eff-f9ce-2751c69fde93	Product name	4	20260122
151279ee-9f3c-b884-3327-05b3fa99d863	Product name	6	20251027

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2022-12-01	These highlights do not include all the information needed to use EVEROLIMUS TABLETS safely and effectively. See full prescribing information for EVEROLIMUS TABLETS. EVEROLIMUS tablets, for oral use Initial U.S. Approval: 2009
2022-12-01	These highlights do not include all the information needed to use EVEROLIMUS TABLETS safely and effectively. See full prescribing information for EVEROLIMUS TABLETS. EVEROLIMUS tablets, for oral use Initial U.S. Approval: 2009
2022-07-29	These highlights do not include all the information needed to use EVEROLIMUS TABLETS safely and effectively. See full prescribing information for EVEROLIMUS TABLETS. EVEROLIMUS tablets, for oral use Initial U.S. Approval: 2009
2022-07-29	These highlights do not include all the information needed to use EVEROLIMUS TABLETS safely and effectively. See full prescribing information for EVEROLIMUS TABLETS. EVEROLIMUS tablets, for oral use Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49884-119-52	Everolimus	1 in 1 BLISTER PACK	TABLET	1		23
49884-119-91	Everolimus	28 in 1 CARTON	TABLET	28		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-119-52	EA - Each	49884-119	bc1cc618-433e-403a-bdef-f21c8f7c0d08	1	2020-01-03
49884-119-91	EA - Each	49884-119	f309a99a-3347-4f7f-bc37-93730fc5a6e4	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49884-119	EVEROLIMUS TABLET [ENDO USA, INC.]	21	Legacy NDC, 2 package rows	20240709_45d54974-3fc4-4237-a2fa-3158ca1a8105.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
845507	everolimus 10 MG Oral Tablet	PSN	45d54974-3fc4-4237-a2fa-3158ca1a8105	23
998189	everolimus 2.5 MG Oral Tablet	PSN	45d54974-3fc4-4237-a2fa-3158ca1a8105	23
845515	everolimus 5 MG Oral Tablet	PSN	45d54974-3fc4-4237-a2fa-3158ca1a8105	23
1119400	everolimus 7.5 MG Oral Tablet	PSN	45d54974-3fc4-4237-a2fa-3158ca1a8105	23
845507	everolimus 10 MG Oral Tablet	SCD	45d54974-3fc4-4237-a2fa-3158ca1a8105	23
998189	everolimus 2.5 MG Oral Tablet	SCD	45d54974-3fc4-4237-a2fa-3158ca1a8105	23
845515	everolimus 5 MG Oral Tablet	SCD	45d54974-3fc4-4237-a2fa-3158ca1a8105	23
1119400	everolimus 7.5 MG Oral Tablet	SCD	45d54974-3fc4-4237-a2fa-3158ca1a8105	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-119-52	49884011952	1 in 1 BLISTER PACK						Historical
49884-119-91	49884011991	28 BLISTER PACK in 1 CARTON (49884-119-91) > 1 TABLET in 1 BLISTER PACK (49884-119-52)	28 blister pack	2019-12-10	0000-00-00	No	No	Current