Home NDC 80803-153 FYARRO
Product NDC 80803-153
11-digit product format 808030153
Labeler code 80803
Product ID 80803-153_b04b03ee-fc3b-411d-a3ef-dfc537c3d6f0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sirolimus
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route INTRAVENOUS
Labeler Aadi Bioscience, Inc.
Application NDA213312
Marketing category NDA
Marketing start 2021-12-06
Substance SIROLIMUS
Active strength 5 mg/mL
Pharmacologic classes 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213312-001 FYARRO SIROLIMUS 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22
Orange Book patents# Current patent rows page 1 of 1 · 9 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213312-001 8911786 2029-02-14 U-3259 Drug product 2021-12-17 N213312-001 10206887 2030-04-15 Drug product 2021-12-17 N213312-001 10705070 2036-03-05 Drug product 2021-12-17 N213312-001 12061183 2036-03-05 Drug product 2024-08-13 N213312-001 10973806 2036-06-29 U-3258 2021-12-17 N213312-001 12133844 2036-06-29 U-4040 2024-12-04 N213312-001 12133844 2036-06-29 U-4041 2024-12-04 N213312-001 12133844 2036-06-29 U-4042 2024-12-04 N213312-001 11497737 2040-10-28 Drug product 2022-11-23
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213312-001 ODE-386 2028-11-22
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 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213312-001 FYARRO 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-11-22 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 6 · 205 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N213312-001 8911786 2029-02-14 U-3259 Drug product 2021-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213312-001 10206887 2030-04-15 Drug product 2021-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213312-001 10705070 2036-03-05 Drug product 2021-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213312-001 12061183 2036-03-05 Drug product 2024-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213312-001 10973806 2036-06-29 U-3258 2021-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213312-001 12133844 2036-06-29 U-4040 2024-12-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213312-001 12133844 2036-06-29 U-4041 2024-12-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213312-001 12133844 2036-06-29 U-4042 2024-12-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213312-001 11497737 2040-10-28 Drug product 2022-11-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213312-001 8911786 2029-02-14 U-3259 Drug product 2021-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213312-001 10206887 2030-04-15 Drug product 2021-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213312-001 10705070 2036-03-05 Drug product 2021-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213312-001 12061183 2036-03-05 Drug product 2024-08-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213312-001 10973806 2036-06-29 U-3258 2021-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213312-001 12133844 2036-06-29 U-4040 2024-12-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213312-001 12133844 2036-06-29 U-4041 2024-12-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213312-001 12133844 2036-06-29 U-4042 2024-12-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213312-001 11497737 2040-10-28 Drug product 2022-11-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213312-001 8911786 2029-02-14 U-3259 Drug product 2021-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213312-001 10206887 2030-04-15 Drug product 2021-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213312-001 10705070 2036-03-05 Drug product 2021-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213312-001 12061183 2036-03-05 Drug product 2024-08-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213312-001 10973806 2036-06-29 U-3258 2021-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213312-001 12133844 2036-06-29 U-4040 2024-12-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213312-001 12133844 2036-06-29 U-4041 2024-12-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213312-001 12133844 2036-06-29 U-4042 2024-12-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213312-001 11497737 2040-10-28 Drug product 2022-11-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213312-001 8911786 2029-02-14 U-3259 Drug product 2021-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213312-001 10206887 2030-04-15 Drug product 2021-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213312-001 10705070 2036-03-05 Drug product 2021-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213312-001 12061183 2036-03-05 Drug product 2024-08-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213312-001 10973806 2036-06-29 U-3258 2021-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213312-001 12133844 2036-06-29 U-4040 2024-12-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213312-001 12133844 2036-06-29 U-4041 2024-12-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213312-001 12133844 2036-06-29 U-4042 2024-12-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213312-001 11497737 2040-10-28 Drug product 2022-11-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213312-001 8911786 2029-02-14 U-3259 Drug product 2021-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213312-001 10206887 2030-04-15 Drug product 2021-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213312-001 10705070 2036-03-05 Drug product 2021-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213312-001 12061183 2036-03-05 Drug product 2024-08-13 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 51 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 FYARRO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SIROLIMUS 5 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80803-153-50 FYARRO 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 9 80803-153-50 FYARRO 20 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 20 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80803-153 FYARRO (SIROLIMUS) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [AADI BIOSCIENCE] 6 Current NDC, Legacy NDC, 2 package rows 20241030_0f9bb784-53e2-46f9-a65d-1c6c2a230eaf.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 80803-153-50 80803015350 1 VIAL, SINGLE-USE in 1 CARTON (80803-153-50) / 20 mL in 1 VIAL, SINGLE-USE 2021-12-06 0000-00-00 No No Current