Zokinvy

Product NDC
73079-050
11-digit product format
730790050
Labeler code
73079
Product ID
73079-050_a747db60-6b1d-11eb-8572-0800200c9a66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lonafarnib
Dosage form
CAPSULE
Route
ORAL
Labeler
Eiger BioPharmaceuticals, Inc.
Application
NDA213969
Marketing category
NDA
Marketing start
2020-11-20
Marketing end
0000-00-00
Substance
LONAFARNIB
Active strength
50 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct73079-050IInactivated by FDA2026-08-11
excluded packagepackage73079-05073079-050-30IInactivated by FDA2026-08-11

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N213969-001ZOKINVYLONAFARNIB50MGCAPSULE / ORALRLD2020-11-20
N213969-002ZOKINVYLONAFARNIB75MGCAPSULE / ORALRLD, RS2020-11-20

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N213969-00178385312029-07-26U-30702021-02-24
N213969-00278385312029-07-26U-30702021-02-24

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N213969-001ODE-3242027-11-20
N213969-002ODE-3242027-11-20

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.

Product history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N213969-001ZOKINVY50MGCAPSULE / ORALRLD2020-11-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213969-002ZOKINVY75MGCAPSULE / ORALRLD, RS2020-11-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213969-001ZOKINVY50MGCAPSULE / ORALRLD2020-11-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213969-002ZOKINVY75MGCAPSULE / ORALRLD, RS2020-11-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N213969-001ZOKINVY50MGCAPSULE / ORALRLD2020-11-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213969-002ZOKINVY75MGCAPSULE / ORALRLD, RS2020-11-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213969-001ZOKINVY50MGCAPSULE / ORALRLD2020-11-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213969-002ZOKINVY75MGCAPSULE / ORALRLD, RS2020-11-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213969-001ZOKINVY50MGCAPSULE / ORALRLD2020-11-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213969-002ZOKINVY75MGCAPSULE / ORALRLD, RS2020-11-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213969-001ZOKINVY50MGCAPSULE / ORALRLD2020-11-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213969-002ZOKINVY75MGCAPSULE / ORALRLD, RS2020-11-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213969-001ZOKINVY50MGCAPSULE / ORALRLD2020-11-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213969-002ZOKINVY75MGCAPSULE / ORALRLD, RS2020-11-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213969-001ZOKINVY50MGCAPSULE / ORALRLD2020-11-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213969-002ZOKINVY75MGCAPSULE / ORALRLD, RS2020-11-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213969-001ZOKINVY50MGCAPSULE / ORALRLD2020-11-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213969-002ZOKINVY75MGCAPSULE / ORALRLD, RS2020-11-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N213969-001ZOKINVY50MGCAPSULE / ORALRLD2020-11-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N213969-002ZOKINVY75MGCAPSULE / ORALRLD, RS2020-11-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N213969-001ZOKINVY50MGCAPSULE / ORALRLD2020-11-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N213969-002ZOKINVY75MGCAPSULE / ORALRLD, RS2020-11-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N213969-001ZOKINVY50MGCAPSULE / ORALRLD2020-11-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N213969-002ZOKINVY75MGCAPSULE / ORALRLD, RS2020-11-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N213969-001ZOKINVY50MGCAPSULE / ORALRLD2020-11-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N213969-002ZOKINVY75MGCAPSULE / ORALRLD, RS2020-11-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05N213969-001ZOKINVY50MGCAPSULE / ORALRLD2020-11-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05N213969-002ZOKINVY75MGCAPSULE / ORALRLD, RS2020-11-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N213969-001ZOKINVY50MGCAPSULE / ORALRLD2020-11-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N213969-002ZOKINVY75MGCAPSULE / ORALRLD, RS2020-11-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N213969-001ZOKINVY50MGCAPSULE / ORALRLD2020-11-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N213969-002ZOKINVY75MGCAPSULE / ORALRLD, RS2020-11-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N213969-001ZOKINVY50MGCAPSULE / ORALRLD2020-11-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N213969-002ZOKINVY75MGCAPSULE / ORALRLD, RS2020-11-204b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N213969-001ZOKINVY50MGCAPSULE / ORALRLD2020-11-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N213969-002ZOKINVY75MGCAPSULE / ORALRLD, RS2020-11-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N213969-001ZOKINVY50MGCAPSULE / ORALRLD2020-11-20782e0a99824c…
2021-12-28 21:50 UTC2021-12N213969-002ZOKINVY75MGCAPSULE / ORALRLD, RS2020-11-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N213969-001ZOKINVY50MGCAPSULE / ORALRLD2020-11-2087673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N213969-002ZOKINVY75MGCAPSULE / ORALRLD, RS2020-11-2087673890dc5c…

Observed Orange Book patent history#

Patent history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N213969-00178385312029-07-26U-30702021-02-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213969-00278385312029-07-26U-30702021-02-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213969-00188283562025-10-17U-30702021-02-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213969-00178385312029-07-26U-30702021-02-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213969-00288283562025-10-17U-30702021-02-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213969-00278385312029-07-26U-30702021-02-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N213969-00188283562025-10-17U-30702021-02-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213969-00178385312029-07-26U-30702021-02-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213969-00288283562025-10-17U-30702021-02-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213969-00278385312029-07-26U-30702021-02-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213969-00178385312025-07-26U-30702021-02-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213969-00188283562025-10-17U-30702021-02-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213969-00278385312025-07-26U-30702021-02-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213969-00288283562025-10-17U-30702021-02-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213969-00178385312025-07-26U-30702021-02-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213969-00188283562025-10-17U-30702021-02-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213969-00278385312025-07-26U-30702021-02-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213969-00288283562025-10-17U-30702021-02-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213969-00178385312025-07-26U-30702021-02-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213969-00188283562025-10-17U-30702021-02-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213969-00278385312025-07-26U-30702021-02-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213969-00288283562025-10-17U-30702021-02-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213969-00178385312025-07-26U-30702021-02-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213969-00188283562025-10-17U-30702021-02-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213969-00278385312025-07-26U-30702021-02-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213969-00288283562025-10-17U-30702021-02-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213969-00178385312024-07-26U-30702021-02-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213969-00188283562024-10-17U-30702021-02-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213969-00278385312024-07-26U-30702021-02-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213969-00288283562024-10-17U-30702021-02-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213969-00178385312025-07-26U-30702021-02-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213969-00188283562025-10-17U-30702021-02-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213969-00278385312025-07-26U-30702021-02-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213969-00288283562025-10-17U-30702021-02-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N213969-00178385312025-07-26U-30702021-02-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N213969-00188283562025-10-17U-30702021-02-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N213969-00278385312025-07-26U-30702021-02-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N213969-00288283562025-10-17U-30702021-02-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N213969-00178385312024-07-26U-30702021-02-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N213969-00188283562024-10-17U-30702021-02-2479d66fd596c7…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 134 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N213969-001ODE-3242027-11-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213969-002ODE-3242027-11-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213969-001NCE2025-11-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213969-001ODE-3242027-11-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213969-002NCE2025-11-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213969-002ODE-3242027-11-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N213969-001NCE2025-11-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213969-001ODE-3242027-11-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213969-002NCE2025-11-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213969-002ODE-3242027-11-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213969-001NCE2025-11-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213969-001ODE-3242027-11-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213969-002NCE2025-11-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213969-002ODE-3242027-11-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213969-001NCE2025-11-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213969-001ODE-3242027-11-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213969-002NCE2025-11-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213969-002ODE-3242027-11-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213969-001NCE2025-11-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213969-001ODE-3242027-11-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213969-002NCE2025-11-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213969-002ODE-3242027-11-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213969-001NCE2025-11-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213969-001ODE-3242027-11-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213969-002NCE2025-11-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213969-002ODE-3242027-11-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213969-001NCE2025-11-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213969-001ODE-3242027-11-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213969-002NCE2025-11-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213969-002ODE-3242027-11-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213969-001NCE2025-11-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213969-001ODE-3242027-11-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213969-002NCE2025-11-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213969-002ODE-3242027-11-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N213969-001NCE2025-11-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N213969-001ODE-3242027-11-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N213969-002NCE2025-11-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N213969-002ODE-3242027-11-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N213969-001NCE2025-11-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N213969-001ODE-3242027-11-2079d66fd596c7…

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73079-050-30Zokinvy30 in 1 BOTTLE, PLASTICCAPSULE307
73079-050-30Zokinvy1 in 1 CARTONCAPSULE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73079-050-30EA - Each73079-050fce0369f-1b88-47e2-97d8-66e21ff6f63112021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73079-050ZOKINVY (LONAFARNIB) CAPSULE [EIGER BIOPHARMACEUTICALS, INC.]7Legacy NDC, 2 package rows20240405_956a142f-35d6-4fe3-8aef-7e4878d275ed.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
ZokinvyLONAFARNIBSentynl Therapeutics, Inc.97391d0c-943e-4c5a-8423-68e163aa7f502025-07-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 213969
application number: NDA213969

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2467582lonafarnib 50 MG Oral CapsulePSN956a142f-35d6-4fe3-8aef-7e4878d275ed7
2467590lonafarnib 75 MG Oral CapsulePSN956a142f-35d6-4fe3-8aef-7e4878d275ed7
2467588Zokinvy 50 MG Oral CapsulePSN956a142f-35d6-4fe3-8aef-7e4878d275ed7
2467592Zokinvy 75 MG Oral CapsulePSN956a142f-35d6-4fe3-8aef-7e4878d275ed7
2467588lonafarnib 50 MG Oral Capsule [Zokinvy]SBD956a142f-35d6-4fe3-8aef-7e4878d275ed7
2467592lonafarnib 75 MG Oral Capsule [Zokinvy]SBD956a142f-35d6-4fe3-8aef-7e4878d275ed7
2467582lonafarnib 50 MG Oral CapsuleSCD956a142f-35d6-4fe3-8aef-7e4878d275ed7
2467590lonafarnib 75 MG Oral CapsuleSCD956a142f-35d6-4fe3-8aef-7e4878d275ed7
2467588Zokinvy 50 MG Oral CapsuleSY956a142f-35d6-4fe3-8aef-7e4878d275ed7
2467592Zokinvy 75 MG Oral CapsuleSY956a142f-35d6-4fe3-8aef-7e4878d275ed7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
73079-050-30730790050301 BOTTLE, PLASTIC in 1 CARTON (73079-050-30) > 30 CAPSULE in 1 BOTTLE, PLASTIC2020-11-200000-00-00NoNoCurrent