Home NDC 49884-283 Everolimus
Product NDC 49884-283
11-digit product format 498840283
Labeler code 49884
Product ID 49884-283_7523ed83-6f81-4cc8-b815-e646ffa1dd80
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Everolimus
Dosage form TABLET
Route ORAL
Labeler Par Health USA, LLC
Application ANDA205775
Marketing category ANDA
Marketing start 2022-01-26
Substance EVEROLIMUS
Active strength 1 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205775-001 EVEROLIMUS EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-10-18 A205775-002 EVEROLIMUS EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-10-18 A205775-003 EVEROLIMUS EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-10-18 A205775-004 EVEROLIMUS EVEROLIMUS 1MG TABLET / ORAL AB 2021-10-18
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.
Product history page 1 of 4 · 144 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 2026-10-15 13:18:30 2026-09 A205775-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-10-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 A205775-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-10-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 A205775-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-10-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 A205775-004 EVEROLIMUS 1MG TABLET / ORAL AB 2021-10-18 c2088c7a36db…2026-09-14 22:38:34 2026-08 A205775-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-10-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205775-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-10-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205775-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-10-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205775-004 EVEROLIMUS 1MG TABLET / ORAL AB 2021-10-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205775-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-10-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205775-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-10-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205775-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-10-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205775-004 EVEROLIMUS 1MG TABLET / ORAL AB 2021-10-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205775-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-10-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205775-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-10-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205775-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-10-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205775-004 EVEROLIMUS 1MG TABLET / ORAL AB 2021-10-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205775-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-10-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205775-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-10-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205775-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-10-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205775-004 EVEROLIMUS 1MG TABLET / ORAL AB 2021-10-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205775-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-10-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205775-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-10-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205775-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-10-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205775-004 EVEROLIMUS 1MG TABLET / ORAL AB 2021-10-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205775-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-10-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205775-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-10-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205775-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-10-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205775-004 EVEROLIMUS 1MG TABLET / ORAL AB 2021-10-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205775-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-10-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205775-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-10-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205775-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-10-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205775-004 EVEROLIMUS 1MG TABLET / ORAL AB 2021-10-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205775-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-10-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205775-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-10-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205775-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-10-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205775-004 EVEROLIMUS 1MG TABLET / ORAL AB 2021-10-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205775-001 EVEROLIMUS 0.25MG TABLET / ORAL AB 2021-10-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205775-002 EVEROLIMUS 0.5MG TABLET / ORAL AB 2021-10-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205775-003 EVEROLIMUS 0.75MG TABLET / ORAL AB 2021-10-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205775-004 EVEROLIMUS 1MG TABLET / ORAL AB 2021-10-18 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 4 · 144 observed states.
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 1 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49884-283-02 Everolimus 6 in 1 CARTON TABLET 6 15 49884-283-52 Everolimus 10 in 1 BLISTER PACK TABLET 10 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49884-283 EVEROLIMUS TABLET [ENDO USA, INC.] 13 Current NDC, Legacy NDC, 2 package rows 20240802_59cb86d5-8706-4619-b074-af253d3e0b68.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 49884-283-02 49884028302 6 BLISTER PACK in 1 CARTON (49884-283-02) / 10 TABLET in 1 BLISTER PACK (49884-283-52) 6 blister pack 2022-01-26 0000-00-00 No No Current 49884-283-52 49884028352 10 in 1 BLISTER PACK Historical