Home NDC 70954-773 Everolimus
Product NDC 70954-773
11-digit product format 709540773
Labeler code 70954
Product ID 70954-773_ed7f01b0-3660-4785-a057-a32eea78d64b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Everolimus
Dosage form TABLET, FOR SUSPENSION
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA220597
Marketing category ANDA
Marketing start 2025-10-10
Substance EVEROLIMUS
Active strength 2 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 44 .
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 A220597-001 EVEROLIMUS EVEROLIMUS 2MG TABLET, FOR SUSPENSION / ORAL AB 2026-09-21 A220597-002 EVEROLIMUS EVEROLIMUS 3MG TABLET, FOR SUSPENSION / ORAL AB 2026-09-21 A220597-003 EVEROLIMUS EVEROLIMUS 5MG TABLET, FOR SUSPENSION / ORAL AB 2026-09-21
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 2026-10-15 13:18:30 2026-09 A220597-001 EVEROLIMUS 2MG TABLET, FOR SUSPENSION / ORAL AB 2026-09-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A220597-002 EVEROLIMUS 3MG TABLET, FOR SUSPENSION / ORAL AB 2026-09-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A220597-003 EVEROLIMUS 5MG TABLET, FOR SUSPENSION / ORAL AB 2026-09-21 c2088c7a36db…
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 2 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70954-773-20 70954077320 28 BLISTER PACK in 1 CARTON (70954-773-20) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (70954-773-10) 28 blister pack 2025-10-10 No No Current