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
Orange Book products#
| 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#
| 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#
| 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 | 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 | 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#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 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… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214487-001 | 8906938 | 2029-12-21 | Drug substance, Drug product | 2021-11-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214487-001 | 8445515 | 2031-02-03 | Drug substance, Drug product | 2021-11-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214487-001 | 11951214 | 2039-11-27 | Drug product | 2024-04-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214487-001 | 11603356 | 2041-05-29 | U-3558 | Drug substance, Drug product | 2023-04-14 | d8e5a09893c0… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N214487-001 | NCE | 2026-10-07 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N214487-001 | ODE-377 | 2028-10-07 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N214487-001 | NCE | 2026-10-07 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N214487-001 | ODE-377 | 2028-10-07 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214487-001 | NCE | 2026-10-07 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214487-001 | ODE-377 | 2028-10-07 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N214487-001 | NCE | 2026-10-07 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N214487-001 | ODE-377 | 2028-10-07 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214487-001 | NCE | 2026-10-07 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214487-001 | ODE-377 | 2028-10-07 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214487-001 | NCE | 2026-10-07 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214487-001 | ODE-377 | 2028-10-07 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214487-001 | NCE | 2026-10-07 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214487-001 | ODE-377 | 2028-10-07 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214487-001 | NCE | 2026-10-07 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214487-001 | ODE-377 | 2028-10-07 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214487-001 | NCE | 2026-10-07 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214487-001 | ODE-377 | 2028-10-07 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214487-001 | NCE | 2026-10-07 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214487-001 | ODE-377 | 2028-10-07 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N214487-001 | NCE | 2026-10-07 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N214487-001 | ODE-377 | 2028-10-07 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N214487-001 | NCE | 2026-10-07 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N214487-001 | ODE-377 | 2028-10-07 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N214487-001 | NCE | 2026-10-07 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N214487-001 | ODE-377 | 2028-10-07 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N214487-001 | NCE | 2026-10-07 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N214487-001 | ODE-377 | 2028-10-07 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N214487-001 | NCE | 2026-10-07 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N214487-001 | ODE-377 | 2028-10-07 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N214487-001 | NCE | 2026-10-07 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N214487-001 | ODE-377 | 2028-10-07 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N214487-001 | NCE | 2026-10-07 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N214487-001 | ODE-377 | 2028-10-07 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N214487-001 | NCE | 2026-10-07 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N214487-001 | ODE-377 | 2028-10-07 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | N214487-001 | NCE | 2026-10-07 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N214487-001 | ODE-377 | 2028-10-07 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N214487-001 | NCE | 2026-10-07 | 782e0a99824c… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N214487-001 | NCE | 2026-10-07 | 6a51e52b5d6a… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TAVNEOS
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AVACOPAN | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| O880NM097T | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c93cbc0b-29a3-46a5-9c85-41815ea5cf4a | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 9568824a-16f1-4562-8fe9-cce186b76ae8 | Product name | 1 | 20220317 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73556-168-01 | TAVNEOS | 1 in 1 CARTON | CAPSULE | 1 | 13 | |
| 73556-168-01 | TAVNEOS | 180 in 1 BOTTLE, PLASTIC | CAPSULE | 180 | 13 | |
| 73556-168-02 | TAVNEOS | 1 in 1 CARTON | CAPSULE | 1 | 13 | |
| 73556-168-02 | TAVNEOS | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | 13 | |
| 73556-168-96 | TAVNEOS | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | 13 | |
| 73556-168-96 | TAVNEOS | 1 in 1 CARTON | CAPSULE | 1 | 13 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 73556-168-01 | EA - Each | 73556-168 | 3b30410f-3191-468e-94ab-0eda225a5573 | 1 | 2021-11-09 |
| 73556-168-02 | EA - Each | 73556-168 | 1b2d7800-ca5b-40d0-998c-dcd4603dc692 | 1 | 2021-11-09 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| TAVNEOS | AVACOPAN | ChemoCentryx, Inc. | c93cbc0b-29a3-46a5-9c85-41815ea5cf4a | 2026-06-02 | Warnings, Adverse reactions | 214487 NDA214487 73556-168 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2572105 | avacopan 10 MG Oral Capsule | PSN | c93cbc0b-29a3-46a5-9c85-41815ea5cf4a | 13 |
| 2572111 | TAVNEOS 10 MG Oral Capsule | PSN | c93cbc0b-29a3-46a5-9c85-41815ea5cf4a | 13 |
| 2572111 | avacopan 10 MG Oral Capsule [Tavneos] | SBD | c93cbc0b-29a3-46a5-9c85-41815ea5cf4a | 13 |
| 2572105 | avacopan 10 MG Oral Capsule | SCD | c93cbc0b-29a3-46a5-9c85-41815ea5cf4a | 13 |
| 2572111 | Tavneos 10 MG Oral Capsule | SY | c93cbc0b-29a3-46a5-9c85-41815ea5cf4a | 13 |
Packages#
| 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 |