Everolimus

Product NDC: 49884-128
11-digit product format: 498840128
Labeler code: 49884
Product ID: 49884-128_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: 2022-11-29
Marketing end: 0000-00-00
Substance: EVEROLIMUS
Active strength: 10 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	49884-128		D	Discontinued by firm		2026-10-21
excluded package	package	49884-128	49884-128-91	D	Discontinued by firm		2026-10-21

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49884-128-52	Everolimus	7 in 1 BLISTER PACK	TABLET	7		23
49884-128-91	Everolimus	4 in 1 CARTON	TABLET	4		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-128-52	EA - Each	49884-128	7394f33d-a2e6-4d84-bbfb-a71ce2355174	1	2022-12-07
49884-128-91	EA - Each	49884-128	00b01df4-be43-47b2-ba0b-fc17cd0a0491	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49884-128	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
49884-128-52	49884012852	7 in 1 BLISTER PACK						Historical
49884-128-91	49884012891	4 BLISTER PACK in 1 CARTON (49884-128-91) > 7 TABLET in 1 BLISTER PACK (49884-128-52)	4 blister pack	2022-11-29	0000-00-00	No	No	Current