Home NDC 63850-0064 Everolimus
Product NDC 63850-0064
11-digit product format 638500064
Labeler code 63850
Product ID 63850-0064_111c2e93-390f-40c6-a626-6aa45878a801
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Everolimus
Dosage form TABLET
Route ORAL
Labeler Natco Pharma Limited
Application ANDA205432
Marketing category ANDA
Marketing start 2021-05-20
Substance EVEROLIMUS
Active strength .75 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 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 A205432-001 EVEROLIMUS EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-05-20 A205432-002 EVEROLIMUS EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-05-20 A205432-003 EVEROLIMUS EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-05-20 A205432-004 EVEROLIMUS EVEROLIMUS 1MG TABLET / ORAL AB 2025-09-03
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 3 · 106 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 A205432-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-05-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205432-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-05-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205432-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-05-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205432-004 EVEROLIMUS 1MG TABLET / ORAL AB 2025-09-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205432-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205432-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205432-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205432-004 EVEROLIMUS 1MG TABLET / ORAL AB 2025-09-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205432-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-05-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205432-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-05-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205432-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-05-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205432-004 EVEROLIMUS 1MG TABLET / ORAL AB 2025-09-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205432-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-05-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205432-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-05-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205432-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-05-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205432-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-05-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205432-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-05-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205432-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-05-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205432-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-05-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205432-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-05-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205432-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-05-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205432-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-05-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205432-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-05-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205432-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-05-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205432-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-05-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205432-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-05-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205432-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-05-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205432-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-05-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205432-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-05-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205432-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-05-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205432-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-05-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205432-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-05-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205432-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-05-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205432-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-05-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205432-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-05-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205432-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-05-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205432-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-05-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205432-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-05-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205432-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-05-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205432-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-05-20 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 106 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Everolimus
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EVEROLIMUS .75 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 977427 Internal RxNorm lookup 977434 Internal RxNorm lookup 977438 Internal RxNorm lookup 2056895 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 63850-0064-2 Everolimus 6 in 1 CARTON TABLET 6 5 63850-0064-2 Everolimus 10 in 1 BLISTER PACK TABLET 10 5 63850-0064-6 Everolimus 60 in 1 BOTTLE TABLET 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63850-0064 EVEROLIMUS TABLET [NATCO PHARMA LIMITED] 4 Current NDC, Legacy NDC, 3 package rows 20230609_d44998bb-5deb-4ee7-a0a5-979fe3f49557.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 · 2 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 63850-0064-2 63850006402 6 BLISTER PACK in 1 CARTON (63850-0064-2) / 10 TABLET in 1 BLISTER PACK 6 blister pack 2021-05-20 0000-00-00 No No Current 63850-0064-6 63850006406 60 TABLET in 1 BOTTLE (63850-0064-6) 60 tablet 2023-05-26 No No Current