Home NDC 49884-127 Everolimus
Product NDC 49884-127
11-digit product format 498840127
Labeler code 49884
Product ID 49884-127_b474c768-50e2-44da-accf-f1bd3d49ab20
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Everolimus
Dosage form TABLET
Route ORAL
Labeler Par Health USA, LLC
Application ANDA207934
Marketing category ANDA
Marketing start 2019-12-10
Marketing end 2026-07-31
Substance EVEROLIMUS
Active strength 7.5 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
Current FDA listing Yes 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product 49884-127 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 49884-127 49884-127-91 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…
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 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 4 · 154 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 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…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207934-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207934-002 EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207934-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207934-004 EVEROLIMUS 10MG TABLET / ORAL AB 2020-12-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207934-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207934-002 EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207934-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207934-004 EVEROLIMUS 10MG TABLET / ORAL AB 2020-12-09 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 142 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49884-127-52 Everolimus 1 in 1 BLISTER PACK TABLET 1 23 49884-127-91 Everolimus 28 in 1 CARTON TABLET 28 23
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49884-127 EVEROLIMUS TABLET [ENDO USA, INC.] 21 Current NDC, Legacy NDC, 2 package rows 20240709_45d54974-3fc4-4237-a2fa-3158ca1a8105.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49884-127-52 49884012752 1 in 1 BLISTER PACK Historical 49884-127-91 49884012791 28 BLISTER PACK in 1 CARTON (49884-127-91) / 1 TABLET in 1 BLISTER PACK (49884-127-52) 28 blister pack 2019-12-10 2026-07-31 No No Current