everolimus

Product NDC
0378-3096
11-digit product format
003783096
Labeler code
0378
Product ID
0378-3096_d51ed68d-10ee-4bbc-9c97-869744f060dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
everolimus
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA212936
Marketing category
ANDA
Marketing start
2022-12-15
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0378-3096DDiscontinued by firm2026-08-17
excluded packagepackage0378-30960378-3096-85DDiscontinued by firm2026-08-17

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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0378-3096-85d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0378-3096-85f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0378-3096-852ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0378-3096-85a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0378-3096-85cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0378-3096-85cdf11ea48f46…ba0047e9e063…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212936-001EVEROLIMUSEVEROLIMUS2.5MGTABLET / ORAL2020-06-08
A212936-002EVEROLIMUSEVEROLIMUS5MGTABLET / ORAL2020-06-08
A212936-003EVEROLIMUSEVEROLIMUS7.5MGTABLET / ORAL2020-06-08
A212936-004EVEROLIMUSEVEROLIMUS10MGTABLET / ORAL2020-06-08

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 · 152 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A212936-001EVEROLIMUS2.5MGTABLET / ORAL2020-06-08caaa826d4ba7…
2026-08-18 06:07:402026-07A212936-002EVEROLIMUS5MGTABLET / ORAL2020-06-08caaa826d4ba7…
2026-08-18 06:07:402026-07A212936-003EVEROLIMUS7.5MGTABLET / ORAL2020-06-08caaa826d4ba7…
2026-08-18 06:07:402026-07A212936-004EVEROLIMUS10MGTABLET / ORAL2020-06-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212936-001EVEROLIMUS2.5MGTABLET / ORAL2020-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212936-002EVEROLIMUS5MGTABLET / ORAL2020-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212936-003EVEROLIMUS7.5MGTABLET / ORAL2020-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212936-004EVEROLIMUS10MGTABLET / ORAL2020-06-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212936-001EVEROLIMUS2.5MGTABLET / ORAL2020-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212936-002EVEROLIMUS5MGTABLET / ORAL2020-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212936-003EVEROLIMUS7.5MGTABLET / ORAL2020-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212936-004EVEROLIMUS10MGTABLET / ORAL2020-06-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A212936-001EVEROLIMUS2.5MGTABLET / ORAL2020-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212936-002EVEROLIMUS5MGTABLET / ORAL2020-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212936-003EVEROLIMUS7.5MGTABLET / ORAL2020-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212936-004EVEROLIMUS10MGTABLET / ORAL2020-06-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212936-001EVEROLIMUS2.5MGTABLET / ORALAB2020-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212936-002EVEROLIMUS5MGTABLET / ORALAB2020-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212936-003EVEROLIMUS7.5MGTABLET / ORALAB2020-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212936-004EVEROLIMUS10MGTABLET / ORALAB2020-06-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212936-001EVEROLIMUS2.5MGTABLET / ORALAB2020-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212936-002EVEROLIMUS5MGTABLET / ORALAB2020-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212936-003EVEROLIMUS7.5MGTABLET / ORALAB2020-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212936-004EVEROLIMUS10MGTABLET / ORALAB2020-06-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212936-001EVEROLIMUS2.5MGTABLET / ORALAB2020-06-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212936-002EVEROLIMUS5MGTABLET / ORALAB2020-06-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212936-003EVEROLIMUS7.5MGTABLET / ORALAB2020-06-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212936-004EVEROLIMUS10MGTABLET / ORALAB2020-06-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212936-001EVEROLIMUS2.5MGTABLET / ORALAB2020-06-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212936-002EVEROLIMUS5MGTABLET / ORALAB2020-06-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212936-003EVEROLIMUS7.5MGTABLET / ORALAB2020-06-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212936-004EVEROLIMUS10MGTABLET / ORALAB2020-06-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212936-001EVEROLIMUS2.5MGTABLET / ORALAB2020-06-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212936-002EVEROLIMUS5MGTABLET / ORALAB2020-06-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212936-003EVEROLIMUS7.5MGTABLET / ORALAB2020-06-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212936-004EVEROLIMUS10MGTABLET / ORALAB2020-06-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212936-001EVEROLIMUS2.5MGTABLET / ORALAB2020-06-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212936-002EVEROLIMUS5MGTABLET / ORALAB2020-06-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212936-003EVEROLIMUS7.5MGTABLET / ORALAB2020-06-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212936-004EVEROLIMUS10MGTABLET / ORALAB2020-06-08d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212936-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212936-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212936-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212936-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212936-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212936-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212936-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212936-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212936-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212936-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212936-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212936-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212936-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212936-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212936-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212936-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212936-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212936-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212936-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212936-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212936-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212936-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212936-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212936-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212936-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212936-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212936-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212936-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212936-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212936-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212936-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212936-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212936-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212936-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212936-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212936-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212936-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212936-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212936-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212936-004AB11e350fbaab3a…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-3096-85003783096854 BLISTER PACK in 1 CARTON (0378-3096-85) > 7 TABLET in 1 BLISTER PACK (0378-3096-32) 4 blister pack2020-09-100000-00-00NoNoCurrent