RELYVRIO

Product NDC
73063-035
11-digit product format
730630035
Labeler code
73063
Product ID
73063-035_a9d047a0-e5f6-441b-89d5-994766d6afcb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium phenylbutyrate/taurursodiol
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Amylyx Pharmaceuticals Inc
Application
NDA216660
Marketing category
NDA
Marketing start
2022-09-29
Marketing end
0000-00-00
Substance
SODIUM PHENYLBUTYRATE; TAURURSODIOL
Active strength
3 g/1; g/1
Pharmacologic classes
Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct73063-035DDiscontinued by firm2026-10-05
excluded packagepackage73063-03573063-035-03DDiscontinued by firm2026-10-05
excluded packagepackage73063-03573063-035-04DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage73063-035-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage73063-035-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage73063-035-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage73063-035-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage73063-035-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage73063-035-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage73063-035-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage73063-035-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage73063-035-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage73063-035-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage73063-035-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage73063-035-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage73063-035-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage73063-035-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage73063-035-040efc9e666f02…f202fb6c5f17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N216660-001RELYVRIOSODIUM PHENYLBUTYRATE; TAURURSODIOL3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD2022-09-29

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N216660-001102518962033-12-24U-34602022-10-28
N216660-001108571622033-12-24U-34602022-10-28
N216660-001110717422033-12-24Drug product2022-10-28
N216660-00198728652033-12-24U-34602022-10-28
N216660-001115835422040-07-27Drug product2023-03-03

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N216660-001NCE2027-09-29
N216660-001ODE-4112029-09-29

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
2026-09-14 22:38:342026-08N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD2022-09-2984e616aacf4f…
2026-08-18 06:07:402026-07N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD2022-09-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD2022-09-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD2022-09-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD2022-09-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD2022-09-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD2022-09-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD2022-09-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD2022-09-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD, RS2022-09-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD2022-09-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD, RS2022-09-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD, RS2022-09-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD, RS2022-09-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD, RS2022-09-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD, RS2022-09-298072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD, RS2022-09-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD, RS2022-09-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD, RS2022-09-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD, RS2022-09-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD, RS2022-09-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD, RS2022-09-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD, RS2022-09-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD, RS2022-09-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD, RS2022-09-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD, RS2022-09-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD, RS2022-09-29f41ea6bd6efb…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216660-001RELYVRIO3GM/PACKET; 1GM/PACKETFOR SUSPENSION / ORALRLD2022-09-29a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 4 · 133 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N216660-001102518962033-12-24U-34602022-10-2884e616aacf4f…
2026-09-14 22:38:342026-08N216660-001108571622033-12-24U-34602022-10-2884e616aacf4f…
2026-09-14 22:38:342026-08N216660-001110717422033-12-24Drug product2022-10-2884e616aacf4f…
2026-09-14 22:38:342026-08N216660-00198728652033-12-24U-34602022-10-2884e616aacf4f…
2026-09-14 22:38:342026-08N216660-001115835422040-07-27Drug product2023-03-0384e616aacf4f…
2026-08-18 06:07:402026-07N216660-001102518962033-12-24U-34602022-10-28caaa826d4ba7…
2026-08-18 06:07:402026-07N216660-001108571622033-12-24U-34602022-10-28caaa826d4ba7…
2026-08-18 06:07:402026-07N216660-001110717422033-12-24Drug product2022-10-28caaa826d4ba7…
2026-08-18 06:07:402026-07N216660-00198728652033-12-24U-34602022-10-28caaa826d4ba7…
2026-08-18 06:07:402026-07N216660-001115835422040-07-27Drug product2023-03-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N216660-001102518962033-12-24U-34602022-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216660-001108571622033-12-24U-34602022-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216660-001110717422033-12-24Drug product2022-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216660-00198728652033-12-24U-34602022-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216660-001115835422040-07-27Drug product2023-03-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216660-001102518962033-12-24U-34602022-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216660-001108571622033-12-24U-34602022-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216660-001110717422033-12-24Drug product2022-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216660-00198728652033-12-24U-34602022-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216660-001115835422040-07-27Drug product2023-03-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N216660-001102518962033-12-24U-34602022-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216660-001108571622033-12-24U-34602022-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216660-001110717422033-12-24Drug product2022-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216660-00198728652033-12-24U-34602022-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216660-001115835422040-07-27Drug product2023-03-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216660-001102518962033-12-24U-34602022-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216660-001108571622033-12-24U-34602022-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216660-001110717422033-12-24Drug product2022-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216660-00198728652033-12-24U-34602022-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216660-001115835422040-07-27Drug product2023-03-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216660-001102518962033-12-24U-34602022-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216660-001108571622033-12-24U-34602022-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216660-001110717422033-12-24Drug product2022-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216660-00198728652033-12-24U-34602022-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216660-001115835422040-07-27Drug product2023-03-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216660-001102518962033-12-24U-34602022-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216660-001108571622033-12-24U-34602022-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216660-001110717422033-12-24Drug product2022-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216660-00198728652033-12-24U-34602022-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216660-001115835422040-07-27Drug product2023-03-0303ed91905a0d…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N216660-001NCE2027-09-2984e616aacf4f…
2026-09-14 22:38:342026-08N216660-001ODE-4112029-09-2984e616aacf4f…
2026-08-18 06:07:402026-07N216660-001NCE2027-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07N216660-001ODE-4112029-09-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N216660-001NCE2027-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216660-001ODE-4112029-09-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216660-001NCE2027-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216660-001ODE-4112029-09-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N216660-001NCE2027-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216660-001ODE-4112029-09-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216660-001NCE2027-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216660-001ODE-4112029-09-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216660-001NCE2027-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216660-001ODE-4112029-09-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216660-001NCE2027-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216660-001ODE-4112029-09-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216660-001NCE2027-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216660-001ODE-4112029-09-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N216660-001NCE2027-09-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N216660-001ODE-4112029-09-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216660-001NCE2027-09-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216660-001ODE-4112029-09-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N216660-001NCE2027-09-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N216660-001ODE-4112029-09-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N216660-001NCE2027-09-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N216660-001ODE-4112029-09-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N216660-001NCE2027-09-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N216660-001ODE-4112029-09-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N216660-001NCE2027-09-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N216660-001ODE-4112029-09-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N216660-001NCE2027-09-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05N216660-001ODE-4112029-09-298072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N216660-001NCE2027-09-296a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N216660-001ODE-4112029-09-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N216660-001NCE2027-09-291c564ffb4f44…
2024-02-18 07:12 UTC2024-02N216660-001ODE-4112029-09-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N216660-001NCE2027-09-29ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N216660-001ODE-4112029-09-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N216660-001NCE2027-09-29a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N216660-001ODE-4112029-09-29a72a2bbeb626…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73063-035-03EA - Each73063-0351d10b683-f6c6-47f7-b968-a8418f9f4f9412022-11-07
73063-035-04EA - Each73063-0354790142e-4778-49af-902a-b15bddddb23c12022-11-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
73063-035-037306300350356 POWDER, FOR SUSPENSION in 1 CARTON (73063-035-03) 2022-09-290000-00-00NoNoCurrent
73063-035-04730630035047 POWDER, FOR SUSPENSION in 1 CARTON (73063-035-04) 2022-09-290000-00-00NoNoCurrent