Home NDC 80803-153 FYARRO
Product NDC 80803-153
11-digit product format 808030153
Labeler code 80803
Product ID 80803-153_94544e08-d7c0-4154-aa40-46c5298c5528
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 42 .
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 2026-08-18 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 5 · 196 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2025-08-23 18:47 UTC 2025-08 N213312-001 10973806 2036-06-29 U-3258 2021-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213312-001 12133844 2036-06-29 U-4040 2024-12-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213312-001 12133844 2036-06-29 U-4041 2024-12-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213312-001 12133844 2036-06-29 U-4042 2024-12-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213312-001 11497737 2040-10-28 Drug product 2022-11-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213312-001 8911786 2029-02-14 U-3259 Drug product 2021-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213312-001 10206887 2030-04-15 Drug product 2021-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213312-001 10705070 2036-03-05 Drug product 2021-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213312-001 12061183 2036-03-05 Drug product 2024-08-13 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 50 observed states.
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
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W36ZG6FT64 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2586863 Internal RxNorm lookup 2586868 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 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
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 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