Home NDC 0378-3096 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 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 date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0378-3096-85 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0378-3096-85 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0378-3096-85 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0378-3096-85 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0378-3096-85 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0378-3096-85 cdf11ea48f46…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212936-001 EVEROLIMUS EVEROLIMUS 2.5MG TABLET / ORAL 2020-06-08 A212936-002 EVEROLIMUS EVEROLIMUS 5MG TABLET / ORAL 2020-06-08 A212936-003 EVEROLIMUS EVEROLIMUS 7.5MG TABLET / ORAL 2020-06-08 A212936-004 EVEROLIMUS EVEROLIMUS 10MG TABLET / ORAL 2020-06-08
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A212936-001 EVEROLIMUS 2.5MG TABLET / ORAL 2020-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212936-002 EVEROLIMUS 5MG TABLET / ORAL 2020-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212936-003 EVEROLIMUS 7.5MG TABLET / ORAL 2020-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212936-004 EVEROLIMUS 10MG TABLET / ORAL 2020-06-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212936-001 EVEROLIMUS 2.5MG TABLET / ORAL 2020-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212936-002 EVEROLIMUS 5MG TABLET / ORAL 2020-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212936-003 EVEROLIMUS 7.5MG TABLET / ORAL 2020-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212936-004 EVEROLIMUS 10MG TABLET / ORAL 2020-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212936-001 EVEROLIMUS 2.5MG TABLET / ORAL 2020-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212936-002 EVEROLIMUS 5MG TABLET / ORAL 2020-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212936-003 EVEROLIMUS 7.5MG TABLET / ORAL 2020-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212936-004 EVEROLIMUS 10MG TABLET / ORAL 2020-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212936-001 EVEROLIMUS 2.5MG TABLET / ORAL 2020-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212936-002 EVEROLIMUS 5MG TABLET / ORAL 2020-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212936-003 EVEROLIMUS 7.5MG TABLET / ORAL 2020-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212936-004 EVEROLIMUS 10MG TABLET / ORAL 2020-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212936-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2020-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212936-002 EVEROLIMUS 5MG TABLET / ORAL AB 2020-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212936-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2020-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212936-004 EVEROLIMUS 10MG TABLET / ORAL AB 2020-06-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212936-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2020-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212936-002 EVEROLIMUS 5MG TABLET / ORAL AB 2020-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212936-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2020-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212936-004 EVEROLIMUS 10MG TABLET / ORAL AB 2020-06-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212936-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2020-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212936-002 EVEROLIMUS 5MG TABLET / ORAL AB 2020-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212936-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2020-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212936-004 EVEROLIMUS 10MG TABLET / ORAL AB 2020-06-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212936-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2020-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212936-002 EVEROLIMUS 5MG TABLET / ORAL AB 2020-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212936-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2020-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212936-004 EVEROLIMUS 10MG TABLET / ORAL AB 2020-06-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212936-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2020-06-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212936-002 EVEROLIMUS 5MG TABLET / ORAL AB 2020-06-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212936-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2020-06-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212936-004 EVEROLIMUS 10MG TABLET / ORAL AB 2020-06-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212936-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2020-06-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212936-002 EVEROLIMUS 5MG TABLET / ORAL AB 2020-06-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212936-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2020-06-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212936-004 EVEROLIMUS 10MG TABLET / ORAL AB 2020-06-08 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0378-3096-85 00378309685 4 BLISTER PACK in 1 CARTON (0378-3096-85) > 7 TABLET in 1 BLISTER PACK (0378-3096-32) 4 blister pack 2020-09-10 0000-00-00 No No Current