ELEPSIA XR 1500 MG

Product NDC
80705-101
11-digit product format
807050101
Labeler code
80705
Product ID
80705-101_3c463bee-1191-4cab-b4d0-367673db19ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levetiracetam
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
TRIPOINT THERAPEUTICS, LLC
Application
NDA204417
Marketing category
NDA
Marketing start
2021-02-12
Substance
LEVETIRACETAM
Active strength
1500 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N204417-001ELEPSIA XRLEVETIRACETAM1GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-20
N204417-002ELEPSIA XRLEVETIRACETAM1.5GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-20

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N204417-00184259382026-02-22Drug product2019-01-11
N204417-00185357172026-02-22Drug product2019-01-11
N204417-00181633062027-09-03Drug product2019-01-11
N204417-00184311562027-10-31Drug product2019-01-11
N204417-00184703672027-10-31Drug product2019-01-11
N204417-00284259382026-02-22Drug product2019-01-11
N204417-00285357172026-02-22Drug product2019-01-11
N204417-00281633062027-09-03Drug product2019-01-11
N204417-00284311562027-10-31Drug product2019-01-11
N204417-00284703672027-10-31Drug product2019-01-11

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 06:07:402026-07N204417-001ELEPSIA XR1GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N204417-002ELEPSIA XR1.5GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204417-001ELEPSIA XR1GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204417-002ELEPSIA XR1.5GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204417-001ELEPSIA XR1GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204417-002ELEPSIA XR1.5GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N204417-001ELEPSIA XR1GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204417-002ELEPSIA XR1.5GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204417-001ELEPSIA XR1GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204417-002ELEPSIA XR1.5GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204417-001ELEPSIA XR1GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204417-002ELEPSIA XR1.5GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204417-001ELEPSIA XR1GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204417-002ELEPSIA XR1.5GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204417-001ELEPSIA XR1GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204417-002ELEPSIA XR1.5GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204417-001ELEPSIA XR1GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204417-002ELEPSIA XR1.5GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204417-001ELEPSIA XR1GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204417-002ELEPSIA XR1.5GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204417-001ELEPSIA XR1GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N204417-002ELEPSIA XR1.5GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204417-001ELEPSIA XR1GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204417-002ELEPSIA XR1.5GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204417-001ELEPSIA XR1GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204417-002ELEPSIA XR1.5GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204417-001ELEPSIA XR1GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204417-002ELEPSIA XR1.5GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05N204417-001ELEPSIA XR1GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05N204417-002ELEPSIA XR1.5GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204417-001ELEPSIA XR1GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204417-002ELEPSIA XR1.5GMTABLET, EXTENDED RELEASE / ORALRLD, RS2018-12-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N204417-001ELEPSIA XR1GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N204417-002ELEPSIA XR1.5GMTABLET, EXTENDED RELEASE / ORALRLD, RS2018-12-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N204417-001ELEPSIA XR1GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N204417-002ELEPSIA XR1.5GMTABLET, EXTENDED RELEASE / ORALRLD, RS2018-12-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N204417-001ELEPSIA XR1GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N204417-002ELEPSIA XR1.5GMTABLET, EXTENDED RELEASE / ORALRLD, RS2018-12-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N204417-001ELEPSIA XR1GMTABLET, EXTENDED RELEASE / ORALRLD2018-12-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N204417-002ELEPSIA XR1.5GMTABLET, EXTENDED RELEASE / ORALRLD, RS2018-12-20bb7c543d1eb4…

Observed Orange Book patent history#

Patent history page 1 of 11 · 420 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N204417-00184259382026-02-22Drug product2019-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07N204417-00185357172026-02-22Drug product2019-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07N204417-00181633062027-09-03Drug product2019-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07N204417-00184311562027-10-31Drug product2019-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07N204417-00184703672027-10-31Drug product2019-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07N204417-00284259382026-02-22Drug product2019-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07N204417-00285357172026-02-22Drug product2019-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07N204417-00281633062027-09-03Drug product2019-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07N204417-00284311562027-10-31Drug product2019-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07N204417-00284703672027-10-31Drug product2019-01-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204417-00184259382026-02-22Drug product2019-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204417-00185357172026-02-22Drug product2019-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204417-00181633062027-09-03Drug product2019-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204417-00184311562027-10-31Drug product2019-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204417-00184703672027-10-31Drug product2019-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204417-00284259382026-02-22Drug product2019-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204417-00285357172026-02-22Drug product2019-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204417-00281633062027-09-03Drug product2019-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204417-00284311562027-10-31Drug product2019-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204417-00284703672027-10-31Drug product2019-01-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204417-00184259382026-02-22Drug product2019-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204417-00185357172026-02-22Drug product2019-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204417-00181633062027-09-03Drug product2019-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204417-00184311562027-10-31Drug product2019-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204417-00184703672027-10-31Drug product2019-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204417-00284259382026-02-22Drug product2019-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204417-00285357172026-02-22Drug product2019-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204417-00281633062027-09-03Drug product2019-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204417-00284311562027-10-31Drug product2019-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204417-00284703672027-10-31Drug product2019-01-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N204417-00184259382026-02-22Drug product2019-01-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204417-00185357172026-02-22Drug product2019-01-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204417-00181633062027-09-03Drug product2019-01-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204417-00184311562027-10-31Drug product2019-01-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204417-00184703672027-10-31Drug product2019-01-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204417-00284259382026-02-22Drug product2019-01-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204417-00285357172026-02-22Drug product2019-01-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204417-00281633062027-09-03Drug product2019-01-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204417-00284311562027-10-31Drug product2019-01-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204417-00284703672027-10-31Drug product2019-01-116a471c1ec25d…

Additional Listing Data#

Finished product
Yes
Brand name base
ELEPSIA XR 1500 MG
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM1500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
44YRR34555Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1605362Internal RxNorm lookup
1605368Internal RxNorm lookup
1605372Internal RxNorm lookup
1605374Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cac83d47-88a2-4447-a0c0-90b44ffda0acAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80705-101-02ELEPSIA XR 1500 MG2 in 1 BLISTER PACKTABLET, EXTENDED RELEASE25
80705-101-02ELEPSIA XR 1500 MG1 in 1 CARTONTABLET, EXTENDED RELEASE15
80705-101-30ELEPSIA XR 1500 MG30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE305
80705-101-99ELEPSIA XR 1500 MG1 in 1 CARTONTABLET, EXTENDED RELEASE15
80705-101-99ELEPSIA XR 1500 MG7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE75

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80705-101-30EA - Each80705-101ef4d995c-8def-429f-a237-d57e1a44821d12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80705-101ELEPSIA XR 1000 MG (LEVETIRACETAM) TABLET, EXTENDED RELEASE ELEPSIA XR 1500 MG (LEVETIRACETAM) TABLET, EXTENDED RELEASE [TRIPOINT THERAPEUTICS, LLC]5Current NDC, Legacy NDC, 5 package rows20240328_cac83d47-88a2-4447-a0c0-90b44ffda0ac.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
ELEPSIA XR 1000 MGLEVETIRACETAMTRIPOINT THERAPEUTICS, LLCcac83d47-88a2-4447-a0c0-90b44ffda0ac2024-03-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 204417
application number: NDA204417
ndc (product): 80705-101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1605368Elepsia XR 1000 MG 24HR Extended Release Oral TabletPSNcac83d47-88a2-4447-a0c0-90b44ffda0ac5
1605374Elepsia XR 1500 MG 24HR Extended Release Oral TabletPSNcac83d47-88a2-4447-a0c0-90b44ffda0ac5
1605362levETIRAcetam 1000 MG 24HR Extended Release Oral TabletPSNcac83d47-88a2-4447-a0c0-90b44ffda0ac5
1605372levETIRAcetam 1500 MG 24HR Extended Release Oral TabletPSNcac83d47-88a2-4447-a0c0-90b44ffda0ac5
160536824 HR levetiracetam 1000 MG Extended Release Oral Tablet [Elepsia]SBDcac83d47-88a2-4447-a0c0-90b44ffda0ac5
160537424 HR levetiracetam 1500 MG Extended Release Oral Tablet [Elepsia]SBDcac83d47-88a2-4447-a0c0-90b44ffda0ac5
160536224 HR levetiracetam 1000 MG Extended Release Oral TabletSCDcac83d47-88a2-4447-a0c0-90b44ffda0ac5
160537224 HR levetiracetam 1500 MG Extended Release Oral TabletSCDcac83d47-88a2-4447-a0c0-90b44ffda0ac5
160536824 HR Elepsia 1000 MG Extended Release Oral TabletSYcac83d47-88a2-4447-a0c0-90b44ffda0ac5
160537424 HR Elepsia 1500 MG Extended Release Oral TabletSYcac83d47-88a2-4447-a0c0-90b44ffda0ac5
1605368Elepsia XR 1000 MG 24 HR Extended Release Oral TabletSYcac83d47-88a2-4447-a0c0-90b44ffda0ac5
1605374Elepsia XR 1500 MG 24 HR Extended Release Oral TabletSYcac83d47-88a2-4447-a0c0-90b44ffda0ac5
1605362levetiracetam 1000 MG 24 HR Extended Release Oral TabletSYcac83d47-88a2-4447-a0c0-90b44ffda0ac5
1605372levetiracetam 1500 MG 24 HR Extended Release Oral TabletSYcac83d47-88a2-4447-a0c0-90b44ffda0ac5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80705-101-02807050101021 BLISTER PACK in 1 CARTON (80705-101-02) / 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2021-09-290000-00-00NoNoCurrent
80705-101-308070501013030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80705-101-30) 2021-02-120000-00-00NoNoCurrent
80705-101-99807050101991 BLISTER PACK in 1 CARTON (80705-101-99) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2021-02-120000-00-00NoNoCurrent