TAVNEOS

Product NDC
73556-168
11-digit product format
735560168
Labeler code
73556
Product ID
73556-168_55ca1a31-6002-420e-b804-8a5137df45d4
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
2026-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N214487-001TAVNEOSAVACOPAN10MGCAPSULE / ORALRLD, RS2021-10-07

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N214487-00184455152031-02-03Drug substance, Drug product2021-11-03
N214487-00189069382034-01-06Drug substance, Drug product2021-11-03
N214487-001116033562039-11-27U-3558Drug substance, Drug product2023-04-14
N214487-001119512142039-11-27Drug product2024-04-26

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N214487-001NCE2026-10-07
N214487-001ODE-3772028-10-07

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-074b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-07782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-073f0d92c62455…
2023-05-13 08:27 UTC2023-05N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-07053a50430f4f…
2023-01-26 05:58 UTC2023-01N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-07cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N214487-001TAVNEOS10MGCAPSULE / ORALRLD, RS2021-10-07a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 3 · 107 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N214487-00184455152031-02-03Drug substance, Drug product2021-11-03caaa826d4ba7…
2026-08-18 06:07:402026-07N214487-00189069382034-01-06Drug substance, Drug product2021-11-03caaa826d4ba7…
2026-08-18 06:07:402026-07N214487-001116033562039-11-27U-3558Drug substance, Drug product2023-04-14caaa826d4ba7…
2026-08-18 06:07:402026-07N214487-001119512142039-11-27Drug product2024-04-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N214487-00184455152031-02-03Drug substance, Drug product2021-11-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214487-00189069382034-01-06Drug substance, Drug product2021-11-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214487-001116033562039-11-27U-3558Drug substance, Drug product2023-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214487-001119512142039-11-27Drug product2024-04-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214487-00189069382029-12-21Drug substance, Drug product2021-11-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214487-00184455152031-02-03Drug substance, Drug product2021-11-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214487-001119512142039-11-27Drug product2024-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214487-001116033562041-05-29U-3558Drug substance, Drug product2023-04-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N214487-00189069382029-12-21Drug substance, Drug product2021-11-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214487-00184455152031-02-03Drug substance, Drug product2021-11-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214487-001119512142039-11-27Drug product2024-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214487-001116033562041-05-29U-3558Drug substance, Drug product2023-04-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214487-00189069382029-12-21Drug substance, Drug product2021-11-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214487-00184455152031-02-03Drug substance, Drug product2021-11-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214487-001119512142039-11-27Drug product2024-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214487-001116033562041-05-29U-3558Drug substance, Drug product2023-04-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214487-00189069382029-12-21Drug substance, Drug product2021-11-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214487-00184455152031-02-03Drug substance, Drug product2021-11-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214487-001119512142039-11-27Drug product2024-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214487-001116033562041-05-29U-3558Drug substance, Drug product2023-04-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214487-00189069382029-12-21Drug substance, Drug product2021-11-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214487-00184455152031-02-03Drug substance, Drug product2021-11-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214487-001119512142039-11-27Drug product2024-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214487-001116033562041-05-29U-3558Drug substance, Drug product2023-04-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214487-00189069382029-12-21Drug substance, Drug product2021-11-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214487-00184455152031-02-03Drug substance, Drug product2021-11-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214487-001119512142039-11-27Drug product2024-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214487-001116033562041-05-29U-3558Drug substance, Drug product2023-04-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214487-00189069382029-12-21Drug substance, Drug product2021-11-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214487-00184455152031-02-03Drug substance, Drug product2021-11-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214487-001119512142039-11-27Drug product2024-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214487-001116033562041-05-29U-3558Drug substance, Drug product2023-04-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214487-00189069382029-12-21Drug substance, Drug product2021-11-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214487-00184455152031-02-03Drug substance, Drug product2021-11-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214487-001119512142039-11-27Drug product2024-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214487-001116033562041-05-29U-3558Drug substance, Drug product2023-04-14d8e5a09893c0…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 67 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N214487-001NCE2026-10-07caaa826d4ba7…
2026-08-18 06:07:402026-07N214487-001ODE-3772028-10-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N214487-001NCE2026-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214487-001ODE-3772028-10-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214487-001NCE2026-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214487-001ODE-3772028-10-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N214487-001NCE2026-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214487-001ODE-3772028-10-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214487-001NCE2026-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214487-001ODE-3772028-10-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214487-001NCE2026-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214487-001ODE-3772028-10-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214487-001NCE2026-10-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214487-001ODE-3772028-10-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214487-001NCE2026-10-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214487-001ODE-3772028-10-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214487-001NCE2026-10-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214487-001ODE-3772028-10-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214487-001NCE2026-10-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214487-001ODE-3772028-10-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214487-001NCE2026-10-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N214487-001ODE-3772028-10-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214487-001NCE2026-10-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214487-001ODE-3772028-10-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214487-001NCE2026-10-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214487-001ODE-3772028-10-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214487-001NCE2026-10-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214487-001ODE-3772028-10-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05N214487-001NCE2026-10-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05N214487-001ODE-3772028-10-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214487-001NCE2026-10-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214487-001ODE-3772028-10-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N214487-001NCE2026-10-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N214487-001ODE-3772028-10-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N214487-001NCE2026-10-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N214487-001ODE-3772028-10-074b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N214487-001NCE2026-10-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N214487-001ODE-3772028-10-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N214487-001NCE2026-10-07782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N214487-001NCE2026-10-076a51e52b5d6a…

Additional Listing Data#

Finished product
Yes
Brand name base
TAVNEOS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVACOPAN10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O880NM097TInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2572105Internal RxNorm lookup
2572111Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c93cbc0b-29a3-46a5-9c85-41815ea5cf4aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9568824a-16f1-4562-8fe9-cce186b76ae8Product name120220317

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73556-168-01TAVNEOS1 in 1 CARTONCAPSULE113
73556-168-01TAVNEOS180 in 1 BOTTLE, PLASTICCAPSULE18013
73556-168-02TAVNEOS1 in 1 CARTONCAPSULE113
73556-168-02TAVNEOS30 in 1 BOTTLE, PLASTICCAPSULE3013
73556-168-96TAVNEOS30 in 1 BOTTLE, PLASTICCAPSULE3013
73556-168-96TAVNEOS1 in 1 CARTONCAPSULE113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73556-168-01EA - Each73556-1683b30410f-3191-468e-94ab-0eda225a557312021-11-09
73556-168-02EA - Each73556-1681b2d7800-ca5b-40d0-998c-dcd4603dc69212021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73556-168TAVNEOS (AVACOPAN) CAPSULE [CHEMOCENTRYX, INC.]12Current NDC, Legacy NDC, 6 package rows20241215_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TAVNEOSAVACOPANChemoCentryx, Inc.c93cbc0b-29a3-46a5-9c85-41815ea5cf4a2026-06-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 214487
application number: NDA214487
ndc (product): 73556-168

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2572105avacopan 10 MG Oral CapsulePSNc93cbc0b-29a3-46a5-9c85-41815ea5cf4a13
2572111TAVNEOS 10 MG Oral CapsulePSNc93cbc0b-29a3-46a5-9c85-41815ea5cf4a13
2572111avacopan 10 MG Oral Capsule [Tavneos]SBDc93cbc0b-29a3-46a5-9c85-41815ea5cf4a13
2572105avacopan 10 MG Oral CapsuleSCDc93cbc0b-29a3-46a5-9c85-41815ea5cf4a13
2572111Tavneos 10 MG Oral CapsuleSYc93cbc0b-29a3-46a5-9c85-41815ea5cf4a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
73556-168-01735560168011 BOTTLE, PLASTIC in 1 CARTON (73556-168-01) / 180 CAPSULE in 1 BOTTLE, PLASTIC2021-10-180000-00-00NoNoCurrent
73556-168-02735560168021 BOTTLE, PLASTIC in 1 CARTON (73556-168-02) / 30 CAPSULE in 1 BOTTLE, PLASTIC2021-10-180000-00-00NoNoCurrent
73556-168-96735560168961 BOTTLE, PLASTIC in 1 CARTON (73556-168-96) / 30 CAPSULE in 1 BOTTLE, PLASTIC2021-10-18YesNoCurrent