Everolimus

Product NDC: 0054-0480
11-digit product format: 000540480
Labeler code: 0054
Product ID: 0054-0480_7558b1b9-ed53-4abc-8a08-194c945bb00f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Everolimus
Dosage form: TABLET
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA207486
Marketing category: ANDA
Marketing start: 2020-06-08
Substance: EVEROLIMUS
Active strength: 2.5 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: 2026-12-31
Current FDA listing: Yes

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 package	package	0054-0480	0054-0480-14	D	Discontinued by firm		2026-08-17
excluded package	package	0054-0480	0054-0480-22	D	Discontinued by firm		2026-08-17

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 · 14 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	0054-0480-22	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0054-0480-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	0054-0480-22	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0054-0480-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	0054-0480-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	0054-0480-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	0054-0480-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	0054-0480-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	0054-0480-14	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	0054-0480-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	0054-0480-14	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	0054-0480-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	0054-0480-14	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	0054-0480-14	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A207486-001	EVEROLIMUS	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2020-06-08
A207486-002	EVEROLIMUS	EVEROLIMUS	5MG	TABLET / ORAL	AB	2020-06-08
A207486-003	EVEROLIMUS	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2020-06-08
A207486-004	EVEROLIMUS	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-11-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207486-001	AB
A207486-002	AB
A207486-003	AB
A207486-004	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 · 148 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
2026-08-18 06:07:40	2026-07	A207486-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2020-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207486-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2020-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207486-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2020-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207486-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-11-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207486-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2020-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207486-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2020-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207486-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2020-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207486-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207486-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2020-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207486-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2020-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207486-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2020-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207486-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207486-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2020-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207486-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2020-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207486-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2020-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207486-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207486-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2020-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207486-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2020-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207486-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2020-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207486-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207486-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2020-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207486-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2020-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207486-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2020-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207486-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207486-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2020-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207486-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2020-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207486-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2020-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207486-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207486-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2020-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207486-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2020-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207486-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2020-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207486-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207486-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2020-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207486-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2020-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207486-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2020-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207486-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207486-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2020-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207486-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2020-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207486-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2020-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207486-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-11-23	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207486-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207486-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207486-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207486-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207486-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207486-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207486-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207486-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207486-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207486-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207486-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207486-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207486-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207486-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207486-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207486-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207486-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207486-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207486-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207486-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207486-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207486-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207486-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207486-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207486-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207486-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207486-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207486-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207486-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207486-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207486-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207486-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207486-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207486-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207486-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207486-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207486-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207486-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207486-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207486-004	AB	1	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Everolimus
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EVEROLIMUS	2.5 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 · 4 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

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5aaf2fb7-93f6-40d6-941a-9583a3794ce7	Available on FDA.report

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	SPL version
0054-0480-13	Everolimus	30 in 1 BOTTLE	TABLET	30	9
0054-0480-14	Everolimus	28 in 1 BLISTER PACK	TABLET	28	9
0054-0480-14	Everolimus	1 in 1 CARTON	TABLET	1	9
0054-0480-22	Everolimus	90 in 1 BOTTLE	TABLET	90	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0480-13	EA - Each	0054-0480	ccf7d6a2-f601-49a4-84c2-8837276ba041	1	2021-03-02
0054-0480-14	EA - Each	0054-0480	369ab2b0-04a9-46f7-b7ad-8fbbcf0edeb7	1	2020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-0480	EVEROLIMUS TABLET [HIKMA PHARMACEUTICALS USA INC.]	7	Current NDC, Legacy NDC, 4 package rows	20231221_5aaf2fb7-93f6-40d6-941a-9583a3794ce7.zip

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
Everolimus	EVEROLIMUS	Hikma Pharmaceuticals USA Inc.	5aaf2fb7-93f6-40d6-941a-9583a3794ce7	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207486 application number: ANDA207486 ndc (product): 0054-0480

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	5aaf2fb7-93f6-40d6-941a-9583a3794ce7	9
998189	everolimus 2.5 MG Oral Tablet	PSN	5aaf2fb7-93f6-40d6-941a-9583a3794ce7	9
845515	everolimus 5 MG Oral Tablet	PSN	5aaf2fb7-93f6-40d6-941a-9583a3794ce7	9
1119400	everolimus 7.5 MG Oral Tablet	PSN	5aaf2fb7-93f6-40d6-941a-9583a3794ce7	9
845507	everolimus 10 MG Oral Tablet	SCD	5aaf2fb7-93f6-40d6-941a-9583a3794ce7	9
998189	everolimus 2.5 MG Oral Tablet	SCD	5aaf2fb7-93f6-40d6-941a-9583a3794ce7	9
845515	everolimus 5 MG Oral Tablet	SCD	5aaf2fb7-93f6-40d6-941a-9583a3794ce7	9
1119400	everolimus 7.5 MG Oral Tablet	SCD	5aaf2fb7-93f6-40d6-941a-9583a3794ce7	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-0480-13	00054048013	30 TABLET in 1 BOTTLE (0054-0480-13)	30 tablet	2021-02-12	0000-00-00	No	No	Current
0054-0480-14	00054048014	1 BLISTER PACK in 1 CARTON (0054-0480-14) > 28 TABLET in 1 BLISTER PACK	1 blister pack	2020-06-08	0000-00-00	No	No	Current
0054-0480-22	00054048022	90 in 1 BOTTLE						Historical