Eletriptan

Product NDC
59762-2322
11-digit product format
597622322
Labeler code
59762
Product ID
59762-2322_e1db233f-7b92-4130-9dfa-8927a81d2f51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eletriptan hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Greenstone LLC
Application
NDA021016
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2017-07-24
Marketing end
0000-00-00
Substance
ELETRIPTAN HYDROBROMIDE
Active strength
40 mg/1
Pharmacologic classes
Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
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 productproduct59762-2322DDiscontinued by firm2026-08-17
excluded packagepackage59762-232259762-2322-1DDiscontinued by firm2026-08-17

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 · 24 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 packagepackage59762-2322-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59762-2322-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59762-2322-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59762-2322-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59762-2322-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59762-2322-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59762-2322-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59762-2322-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59762-2322-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59762-2322-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59762-2322-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59762-2322-1557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021016-001RELPAXELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALABRLD2002-12-26
N021016-002RELPAXELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALABRLD, RS2002-12-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N021016-001AB
N021016-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021016-001RELPAXEQ 20MG BASETABLET / ORALABRLD2002-12-26caaa826d4ba7…
2026-08-18 06:07:402026-07N021016-002RELPAXEQ 40MG BASETABLET / ORALABRLD, RS2002-12-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021016-001RELPAXEQ 20MG BASETABLET / ORALABRLD2002-12-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021016-002RELPAXEQ 40MG BASETABLET / ORALABRLD, RS2002-12-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021016-001RELPAXEQ 20MG BASETABLET / ORALABRLD2002-12-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021016-002RELPAXEQ 40MG BASETABLET / ORALABRLD, RS2002-12-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N021016-001RELPAXEQ 20MG BASETABLET / ORALABRLD2002-12-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021016-002RELPAXEQ 40MG BASETABLET / ORALABRLD, RS2002-12-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021016-001RELPAXEQ 20MG BASETABLET / ORALABRLD2002-12-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021016-002RELPAXEQ 40MG BASETABLET / ORALABRLD, RS2002-12-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021016-001RELPAXEQ 20MG BASETABLET / ORALABRLD2002-12-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021016-002RELPAXEQ 40MG BASETABLET / ORALABRLD, RS2002-12-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021016-001RELPAXEQ 20MG BASETABLET / ORALABRLD2002-12-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021016-002RELPAXEQ 40MG BASETABLET / ORALABRLD, RS2002-12-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021016-001RELPAXEQ 20MG BASETABLET / ORALABRLD2002-12-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021016-002RELPAXEQ 40MG BASETABLET / ORALABRLD, RS2002-12-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021016-001RELPAXEQ 20MG BASETABLET / ORALABRLD2002-12-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021016-002RELPAXEQ 40MG BASETABLET / ORALABRLD, RS2002-12-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021016-001RELPAXEQ 20MG BASETABLET / ORALABRLD2002-12-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021016-002RELPAXEQ 40MG BASETABLET / ORALABRLD, RS2002-12-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021016-001RELPAXEQ 20MG BASETABLET / ORALABRLD2002-12-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N021016-002RELPAXEQ 40MG BASETABLET / ORALABRLD, RS2002-12-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021016-001RELPAXEQ 20MG BASETABLET / ORALABRLD2002-12-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021016-002RELPAXEQ 40MG BASETABLET / ORALABRLD, RS2002-12-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021016-001RELPAXEQ 20MG BASETABLET / ORALABRLD2002-12-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021016-002RELPAXEQ 40MG BASETABLET / ORALABRLD, RS2002-12-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021016-001RELPAXEQ 20MG BASETABLET / ORALABRLD2002-12-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021016-002RELPAXEQ 40MG BASETABLET / ORALABRLD, RS2002-12-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021016-001RELPAXEQ 20MG BASETABLET / ORALABRLD2002-12-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021016-002RELPAXEQ 40MG BASETABLET / ORALABRLD, RS2002-12-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021016-001RELPAXEQ 20MG BASETABLET / ORALABRLD2002-12-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021016-002RELPAXEQ 40MG BASETABLET / ORALABRLD, RS2002-12-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021016-001RELPAXEQ 20MG BASETABLET / ORALABRLD2002-12-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021016-002RELPAXEQ 40MG BASETABLET / ORALABRLD, RS2002-12-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021016-001RELPAXEQ 20MG BASETABLET / ORALABRLD2002-12-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021016-002RELPAXEQ 40MG BASETABLET / ORALABRLD, RS2002-12-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021016-001RELPAXEQ 20MG BASETABLET / ORALABRLD2002-12-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021016-002RELPAXEQ 40MG BASETABLET / ORALABRLD, RS2002-12-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021016-001RELPAXEQ 20MG BASETABLET / ORALABRLD2002-12-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021016-002RELPAXEQ 40MG BASETABLET / ORALABRLD, RS2002-12-26bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N021016-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021016-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021016-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021016-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021016-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021016-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021016-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021016-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021016-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021016-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021016-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021016-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021016-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021016-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021016-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021016-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021016-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021016-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021016-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021016-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021016-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021016-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021016-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021016-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021016-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021016-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021016-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021016-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021016-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021016-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021016-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021016-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021016-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021016-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021016-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021016-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021016-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021016-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021016-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021016-002AB1bb7c543d1eb4…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-2322-1EA - Each59762-2322642330c0-6a67-4e35-84f9-ba71d32b11b612017-09-11

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
RelpaxELETRIPTAN HYDROBROMIDEViatris Specialty LLC2a501dbd-3ea8-47e4-9fcb-07035b8c8c9e2024-01-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 021016
application number: NDA021016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-2322-1597622322016 BLISTER PACK in 1 CARTON (59762-2322-1) > 1 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2017-07-240000-00-00NoNoCurrent