Home NDC 51991-991 Everolimus
Product NDC 51991-991
11-digit product format 519910991
Labeler code 51991
Product ID 51991-991_fade73fb-a367-4c53-83dd-1352c3ad807b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Everolimus
Dosage form TABLET, FOR SUSPENSION
Route ORAL
Labeler Breckenridge Pharmaceutical, Inc.
Application ANDA217640
Marketing category ANDA
Marketing start 2025-01-28
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 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217640-001 EVEROLIMUS EVEROLIMUS 2MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 A217640-002 EVEROLIMUS EVEROLIMUS 3MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 A217640-003 EVEROLIMUS EVEROLIMUS 5MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 2026-08-18 06:07:40 2026-07 A217640-001 EVEROLIMUS 2MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217640-002 EVEROLIMUS 3MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217640-003 EVEROLIMUS 5MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217640-001 EVEROLIMUS 2MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217640-002 EVEROLIMUS 3MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217640-003 EVEROLIMUS 5MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217640-001 EVEROLIMUS 2MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217640-002 EVEROLIMUS 3MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217640-003 EVEROLIMUS 5MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217640-001 EVEROLIMUS 2MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217640-002 EVEROLIMUS 3MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217640-003 EVEROLIMUS 5MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217640-001 EVEROLIMUS 2MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217640-002 EVEROLIMUS 3MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217640-003 EVEROLIMUS 5MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217640-001 EVEROLIMUS 2MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217640-002 EVEROLIMUS 3MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217640-003 EVEROLIMUS 5MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217640-001 EVEROLIMUS 2MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217640-002 EVEROLIMUS 3MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217640-003 EVEROLIMUS 5MG TABLET, FOR SUSPENSION / ORAL AB 2025-01-28 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Everolimus
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EVEROLIMUS 3 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 · 7 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 1308428 Internal RxNorm lookup 1308430 Internal RxNorm lookup 1308432 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 51991-991-28 Everolimus 4 in 1 CARTON TABLET, FOR SUSPENSION 4 20 51991-991-77 Everolimus 28 in 1 BOTTLE TABLET, FOR SUSPENSION 28 20 51991-991-99 Everolimus 7 in 1 BLISTER PACK TABLET, FOR SUSPENSION 7 20
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51991-991 EVEROLIMUS TABLET EVEROLIMUS TABLET, FOR SUSPENSION [BRECKENRIDGE PHARMACEUTICAL, INC.] 16 Current NDC, 3 package rows 20250130_01f7b5fb-be0d-4adf-acd2-6899018de966.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 Sample Exclude flag Status 51991-991-28 51991099128 4 BLISTER PACK in 1 CARTON (51991-991-28) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK (51991-991-99) 4 blister pack 2025-01-28 No No Current 51991-991-77 51991099177 28 TABLET, FOR SUSPENSION in 1 BOTTLE (51991-991-77) 2025-07-31 No No Current 51991-991-99 51991099199 7 in 1 BLISTER PACK Historical