Home NDC 0093-7769 Everolimus
Product NDC 0093-7769
11-digit product format 000937769
Labeler code 0093
Product ID 0093-7769_aa521933-950a-441b-9146-93e479a4dde7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Everolimus
Dosage form TABLET
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA210050
Marketing category ANDA
Marketing start 2023-10-23
Marketing end 2026-09-30
Substance EVEROLIMUS
Active strength 10 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 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 A210050-001 EVEROLIMUS EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 A210050-002 EVEROLIMUS EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 A210050-003 EVEROLIMUS EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 A210050-004 EVEROLIMUS EVEROLIMUS 10MG TABLET / ORAL AB 2019-12-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 · 156 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 A210050-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210050-002 EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210050-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210050-004 EVEROLIMUS 10MG TABLET / ORAL AB 2019-12-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210050-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210050-002 EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210050-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210050-004 EVEROLIMUS 10MG TABLET / ORAL AB 2019-12-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210050-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210050-002 EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210050-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210050-004 EVEROLIMUS 10MG TABLET / ORAL AB 2019-12-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210050-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210050-002 EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210050-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210050-004 EVEROLIMUS 10MG TABLET / ORAL AB 2019-12-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210050-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210050-002 EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210050-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210050-004 EVEROLIMUS 10MG TABLET / ORAL AB 2019-12-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210050-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210050-002 EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210050-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210050-004 EVEROLIMUS 10MG TABLET / ORAL AB 2019-12-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210050-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210050-002 EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210050-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210050-004 EVEROLIMUS 10MG TABLET / ORAL AB 2019-12-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210050-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210050-002 EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210050-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210050-004 EVEROLIMUS 10MG TABLET / ORAL AB 2019-12-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210050-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210050-002 EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210050-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210050-004 EVEROLIMUS 10MG TABLET / ORAL AB 2019-12-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210050-001 EVEROLIMUS 2.5MG TABLET / ORAL AB 2019-12-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210050-002 EVEROLIMUS 5MG TABLET / ORAL AB 2019-12-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210050-003 EVEROLIMUS 7.5MG TABLET / ORAL AB 2019-12-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210050-004 EVEROLIMUS 10MG TABLET / ORAL AB 2019-12-09 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 141 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Everolimus Active Ingredients# Ingredient, Strength table Ingredient Strength EVEROLIMUS 10 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0093-7769-19 Everolimus 1 in 1 BLISTER PACK TABLET 1 10 0093-7769-24 Everolimus 28 in 1 CARTON TABLET 28 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-7769 EVEROLIMUS TABLET [TEVA PHARMACEUTICALS USA, INC.] 8 Current NDC, 2 package rows 20250216_e3bca36b-29ed-4a2b-a1be-a57b6af805f6.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.
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 0093-7769-19 00093776919 1 in 1 BLISTER PACK Historical 0093-7769-24 00093776924 28 BLISTER PACK in 1 CARTON (0093-7769-24) / 1 TABLET in 1 BLISTER PACK (0093-7769-19) 28 blister pack 2023-10-23 2026-09-30 No No Historical