Home NDC 0054-0471 Everolimus
Product NDC 0054-0471
11-digit product format 000540471
Labeler code 0054
Product ID 0054-0471_496ea375-42a1-422e-88ad-0b1c6df703aa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Everolimus
Dosage form TABLET
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA206133
Marketing category ANDA
Marketing start 2020-03-10
Substance EVEROLIMUS
Active strength .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
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A206133-001 EVEROLIMUS EVEROLIMUS 0.25MG TABLET / ORAL AB 2018-04-12 A206133-002 EVEROLIMUS EVEROLIMUS 0.5MG TABLET / ORAL AB 2018-04-12 A206133-003 EVEROLIMUS EVEROLIMUS 0.75MG TABLET / ORAL AB 2018-04-12 A206133-004 EVEROLIMUS EVEROLIMUS 1MG TABLET / ORAL AB 2021-11-18
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.
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 2026-08-01 22:54:32 2026-06 A206133-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2018-04-12 a50c72e98297…2026-08-01 22:54:32 2026-06 A206133-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2018-04-12 a50c72e98297…2026-08-01 22:54:32 2026-06 A206133-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2018-04-12 a50c72e98297…2026-08-01 22:54:32 2026-06 A206133-004 EVEROLIMUS 1MG TABLET / ORAL AB 2021-11-18 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Everolimus
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EVEROLIMUS .5 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 0054-0471-21 Everolimus 60 in 1 BOTTLE TABLET 60 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0471 EVEROLIMUS TABLET [HIKMA PHARMACEUTICALS USA INC.] 8 Current NDC, Legacy NDC, 1 package rows 20250416_cf2dd54b-7a1d-4401-9a01-75e68235e433.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 0054-0471-21 00054047121 60 TABLET in 1 BOTTLE (0054-0471-21) 60 tablet 2020-03-10 0000-00-00 No No Current