Home NDC 72319-016 Everolimus
Product NDC 72319-016
11-digit product format 723190016
Labeler code 72319
Product ID 72319-016_5afb5d8b-631c-48bd-e063-6294a90acfe3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name everolimus
Dosage form TABLET
Route ORAL
Labeler i3 Pharmaceuticals, LLC
Application ANDA219464
Marketing category ANDA
Marketing start 2026-08-07
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A219464-001 EVEROLIMUS EVEROLIMUS 0.25MG TABLET / ORAL AB 2026-06-30 A219464-002 EVEROLIMUS EVEROLIMUS 0.5MG TABLET / ORAL AB 2026-06-30 A219464-003 EVEROLIMUS EVEROLIMUS 0.75MG TABLET / ORAL AB 2026-06-30 A219464-004 EVEROLIMUS EVEROLIMUS 1MG TABLET / ORAL AB 2026-06-30
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 2026-09-14 22:38:34 2026-08 A219464-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2026-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219464-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2026-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219464-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2026-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219464-004 EVEROLIMUS 1MG TABLET / ORAL AB 2026-06-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219464-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2026-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219464-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2026-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219464-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2026-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219464-004 EVEROLIMUS 1MG TABLET / ORAL AB 2026-06-30 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219464-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2026-06-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219464-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2026-06-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219464-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2026-06-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219464-004 EVEROLIMUS 1MG TABLET / ORAL AB 2026-06-30 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Everolimus
Listing expiration 2027-12-31 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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72319-016-02 72319001602 60 TABLET in 1 CONTAINER (72319-016-02) 60 tablet 2026-08-07 No No Current 72319-016-60 72319001660 60 BLISTER PACK in 1 CARTON (72319-016-60) / 10 TABLET in 1 BLISTER PACK (72319-016-10) 60 blister pack 2026-08-07 No No Current