Home NDC 73556-168 TAVNEOS
Product NDC 73556-168
11-digit product format 735560168
Labeler code 73556
Product ID 73556-168_35c096c8-3581-4d09-b01c-d6e514e0c836
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name avacopan
Dosage form CAPSULE
Route ORAL
Labeler ChemoCentryx, Inc.
Application NDA214487
Marketing category NDA
Marketing start 2021-10-18
Substance AVACOPAN
Active strength 10 mg/1
Pharmacologic classes Complement 5a Receptor Antagonist [EPC], Complement 5a Receptor Antagonists [MoA], Cytochrome P450 3A4 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 N214487-001 TAVNEOS AVACOPAN 10MG CAPSULE / ORAL RLD, RS 2021-10-07
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214487-001 8445515 2031-02-03 Drug substance, Drug product 2021-11-03 N214487-001 8906938 2034-01-06 Drug substance, Drug product 2021-11-03 N214487-001 11603356 2039-11-27 U-3558 Drug substance, Drug product 2023-04-14 N214487-001 11951214 2039-11-27 Drug product 2024-04-26
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214487-001 NCE 2026-10-07 N214487-001 ODE-377 2028-10-07
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 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214487-001 TAVNEOS 10MG CAPSULE / ORAL RLD, RS 2021-10-07 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 111 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 N214487-001 8445515 2031-02-03 Drug substance, Drug product 2021-11-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214487-001 8906938 2034-01-06 Drug substance, Drug product 2021-11-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214487-001 11603356 2039-11-27 U-3558 Drug substance, Drug product 2023-04-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214487-001 11951214 2039-11-27 Drug product 2024-04-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214487-001 8445515 2031-02-03 Drug substance, Drug product 2021-11-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214487-001 8906938 2034-01-06 Drug substance, Drug product 2021-11-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214487-001 11603356 2039-11-27 U-3558 Drug substance, Drug product 2023-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214487-001 11951214 2039-11-27 Drug product 2024-04-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214487-001 8445515 2031-02-03 Drug substance, Drug product 2021-11-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214487-001 8906938 2034-01-06 Drug substance, Drug product 2021-11-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214487-001 11603356 2039-11-27 U-3558 Drug substance, Drug product 2023-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214487-001 11951214 2039-11-27 Drug product 2024-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214487-001 8906938 2029-12-21 Drug substance, Drug product 2021-11-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214487-001 8445515 2031-02-03 Drug substance, Drug product 2021-11-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214487-001 11951214 2039-11-27 Drug product 2024-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214487-001 11603356 2041-05-29 U-3558 Drug substance, Drug product 2023-04-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214487-001 8906938 2029-12-21 Drug substance, Drug product 2021-11-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214487-001 8445515 2031-02-03 Drug substance, Drug product 2021-11-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214487-001 11951214 2039-11-27 Drug product 2024-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214487-001 11603356 2041-05-29 U-3558 Drug substance, Drug product 2023-04-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214487-001 8906938 2029-12-21 Drug substance, Drug product 2021-11-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214487-001 8445515 2031-02-03 Drug substance, Drug product 2021-11-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214487-001 11951214 2039-11-27 Drug product 2024-04-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214487-001 11603356 2041-05-29 U-3558 Drug substance, Drug product 2023-04-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214487-001 8906938 2029-12-21 Drug substance, Drug product 2021-11-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214487-001 8445515 2031-02-03 Drug substance, Drug product 2021-11-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214487-001 11951214 2039-11-27 Drug product 2024-04-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214487-001 11603356 2041-05-29 U-3558 Drug substance, Drug product 2023-04-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214487-001 8906938 2029-12-21 Drug substance, Drug product 2021-11-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214487-001 8445515 2031-02-03 Drug substance, Drug product 2021-11-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214487-001 11951214 2039-11-27 Drug product 2024-04-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214487-001 11603356 2041-05-29 U-3558 Drug substance, Drug product 2023-04-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214487-001 8906938 2029-12-21 Drug substance, Drug product 2021-11-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214487-001 8445515 2031-02-03 Drug substance, Drug product 2021-11-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214487-001 11951214 2039-11-27 Drug product 2024-04-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214487-001 11603356 2041-05-29 U-3558 Drug substance, Drug product 2023-04-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214487-001 8906938 2029-12-21 Drug substance, Drug product 2021-11-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214487-001 8445515 2031-02-03 Drug substance, Drug product 2021-11-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214487-001 11951214 2039-11-27 Drug product 2024-04-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214487-001 11603356 2041-05-29 U-3558 Drug substance, Drug product 2023-04-14 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 69 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 TAVNEOS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVACOPAN 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O880NM097T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2572105 Internal RxNorm lookup 2572111 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73556-168 TAVNEOS (AVACOPAN) CAPSULE [CHEMOCENTRYX, INC.] 12 Current NDC, Legacy NDC, 6 package rows 20241215_c93cbc0b-29a3-46a5-9c85-41815ea5cf4a.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 73556-168-01 73556016801 1 BOTTLE, PLASTIC in 1 CARTON (73556-168-01) / 180 CAPSULE in 1 BOTTLE, PLASTIC 2021-10-18 0000-00-00 No No Current 73556-168-02 73556016802 1 BOTTLE, PLASTIC in 1 CARTON (73556-168-02) / 30 CAPSULE in 1 BOTTLE, PLASTIC 2021-10-18 0000-00-00 No No Current 73556-168-96 73556016896 1 BOTTLE, PLASTIC in 1 CARTON (73556-168-96) / 30 CAPSULE in 1 BOTTLE, PLASTIC 2021-10-18 Yes No Current