Everolimus

Product NDC: 49884-158
Requested package NDC: 49884-158-02
11-digit product format: 498840158
Labeler code: 49884
Product ID: 49884-158_9a6bc6cc-b9da-4fe1-9ee1-c9a393bb5dec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Everolimus
Dosage form: TABLET
Route: ORAL
Labeler: Par Pharmaceutical, Inc.
Application: ANDA205775
Marketing category: ANDA
Marketing start: 2022-03-31
Marketing end: 0000-00-00
Substance: EVEROLIMUS
Active strength: 0 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	49884-158	49884-158-02	D	Discontinued by firm		2026-10-20

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	TE codes	Approval date
A205775-001	EVEROLIMUS	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-10-18
A205775-002	EVEROLIMUS	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-10-18
A205775-003	EVEROLIMUS	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-10-18
A205775-004	EVEROLIMUS	EVEROLIMUS	1MG	TABLET / ORAL	AB	2021-10-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205775-001	AB
A205775-002	AB
A205775-003	AB
A205775-004	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
2026-10-15 13:18:30	2026-09	A205775-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-10-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205775-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-10-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205775-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-10-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205775-004	EVEROLIMUS	1MG	TABLET / ORAL	AB	2021-10-18	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A205775-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205775-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205775-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205775-004	EVEROLIMUS	1MG	TABLET / ORAL	AB	2021-10-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205775-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205775-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205775-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205775-004	EVEROLIMUS	1MG	TABLET / ORAL	AB	2021-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205775-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205775-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205775-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205775-004	EVEROLIMUS	1MG	TABLET / ORAL	AB	2021-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205775-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205775-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205775-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205775-004	EVEROLIMUS	1MG	TABLET / ORAL	AB	2021-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205775-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205775-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205775-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205775-004	EVEROLIMUS	1MG	TABLET / ORAL	AB	2021-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205775-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205775-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205775-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205775-004	EVEROLIMUS	1MG	TABLET / ORAL	AB	2021-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205775-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205775-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205775-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205775-004	EVEROLIMUS	1MG	TABLET / ORAL	AB	2021-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205775-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205775-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205775-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205775-004	EVEROLIMUS	1MG	TABLET / ORAL	AB	2021-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205775-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205775-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205775-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205775-004	EVEROLIMUS	1MG	TABLET / ORAL	AB	2021-10-18	`2680178bc6a6…`

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
2026-10-15 13:18:30	2026-09	A205775-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205775-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205775-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205775-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A205775-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205775-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205775-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205775-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205775-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205775-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205775-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205775-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205775-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205775-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205775-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205775-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205775-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205775-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205775-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205775-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205775-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205775-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205775-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205775-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205775-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205775-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205775-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205775-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205775-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205775-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205775-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205775-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205775-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205775-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205775-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205775-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205775-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205775-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205775-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205775-004	AB	1	`2680178bc6a6…`

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
49884-158-02	Everolimus	6 in 1 CARTON	TABLET	6		15
49884-158-52	Everolimus	10 in 1 BLISTER PACK	TABLET	10		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-158-02	EA - Each	49884-158	b65dba2e-e663-4e08-8421-21c07aea108c	1	2023-04-07
49884-158-52	EA - Each	49884-158	c08f39d8-6b85-4289-9a2d-b089e56461fe	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49884-158	EVEROLIMUS TABLET [ENDO USA, INC.]	13	Legacy NDC, 2 package rows	20240802_59cb86d5-8706-4619-b074-af253d3e0b68.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
977427	everolimus 0.25 MG Oral Tablet	PSN	59cb86d5-8706-4619-b074-af253d3e0b68	15
977434	everolimus 0.5 MG Oral Tablet	PSN	59cb86d5-8706-4619-b074-af253d3e0b68	15
977438	everolimus 0.75 MG Oral Tablet	PSN	59cb86d5-8706-4619-b074-af253d3e0b68	15
2056895	everolimus 1 MG Oral Tablet	PSN	59cb86d5-8706-4619-b074-af253d3e0b68	15
977427	everolimus 0.25 MG Oral Tablet	SCD	59cb86d5-8706-4619-b074-af253d3e0b68	15
977434	everolimus 0.5 MG Oral Tablet	SCD	59cb86d5-8706-4619-b074-af253d3e0b68	15
977438	everolimus 0.75 MG Oral Tablet	SCD	59cb86d5-8706-4619-b074-af253d3e0b68	15
2056895	everolimus 1 MG Oral Tablet	SCD	59cb86d5-8706-4619-b074-af253d3e0b68	15
977434	everolimus 500 MCG Oral Tablet	SY	59cb86d5-8706-4619-b074-af253d3e0b68	15
977438	everolimus 750 MCG Oral Tablet	SY	59cb86d5-8706-4619-b074-af253d3e0b68	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-158-02	49884015802	6 BLISTER PACK in 1 CARTON (49884-158-02) > 10 TABLET in 1 BLISTER PACK (49884-158-52)	6 blister pack	2022-03-31	0000-00-00	No	No	Current