Levetiracetam

Product NDC
70518-1796
Requested package NDC
70518-1796-1
11-digit product format
705181796
Labeler code
70518
Product ID
70518-1796_4aa50726-6ff8-31e1-e063-6294a90a522c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090515
Marketing category
ANDA
Marketing start
2019-01-14
Substance
LEVETIRACETAM
Active strength
500 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-179670518-1796-1DDiscontinued by firm2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090515-001LEVETIRACETAMLEVETIRACETAM250MGTABLET / ORALAB2010-10-08
A090515-002LEVETIRACETAMLEVETIRACETAM500MGTABLET / ORALAB2010-10-08
A090515-003LEVETIRACETAMLEVETIRACETAM750MGTABLET / ORALAB2010-10-08
A090515-004LEVETIRACETAMLEVETIRACETAM1GMTABLET / ORALAB2010-10-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A090515-001AB
A090515-002AB
A090515-003AB
A090515-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090515-001LEVETIRACETAM250MGTABLET / ORALAB2010-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090515-002LEVETIRACETAM500MGTABLET / ORALAB2010-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090515-003LEVETIRACETAM750MGTABLET / ORALAB2010-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090515-004LEVETIRACETAM1GMTABLET / ORALAB2010-10-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090515-001LEVETIRACETAM250MGTABLET / ORALAB2010-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090515-002LEVETIRACETAM500MGTABLET / ORALAB2010-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090515-003LEVETIRACETAM750MGTABLET / ORALAB2010-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090515-004LEVETIRACETAM1GMTABLET / ORALAB2010-10-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A090515-001LEVETIRACETAM250MGTABLET / ORALAB2010-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090515-002LEVETIRACETAM500MGTABLET / ORALAB2010-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090515-003LEVETIRACETAM750MGTABLET / ORALAB2010-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090515-004LEVETIRACETAM1GMTABLET / ORALAB2010-10-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090515-001LEVETIRACETAM250MGTABLET / ORALAB2010-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090515-002LEVETIRACETAM500MGTABLET / ORALAB2010-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090515-003LEVETIRACETAM750MGTABLET / ORALAB2010-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090515-004LEVETIRACETAM1GMTABLET / ORALAB2010-10-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090515-001LEVETIRACETAM250MGTABLET / ORALAB2010-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090515-002LEVETIRACETAM500MGTABLET / ORALAB2010-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090515-003LEVETIRACETAM750MGTABLET / ORALAB2010-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090515-004LEVETIRACETAM1GMTABLET / ORALAB2010-10-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090515-001LEVETIRACETAM250MGTABLET / ORALAB2010-10-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090515-002LEVETIRACETAM500MGTABLET / ORALAB2010-10-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090515-003LEVETIRACETAM750MGTABLET / ORALAB2010-10-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090515-004LEVETIRACETAM1GMTABLET / ORALAB2010-10-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090515-001LEVETIRACETAM250MGTABLET / ORALAB2010-10-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090515-002LEVETIRACETAM500MGTABLET / ORALAB2010-10-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090515-003LEVETIRACETAM750MGTABLET / ORALAB2010-10-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090515-004LEVETIRACETAM1GMTABLET / ORALAB2010-10-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090515-001LEVETIRACETAM250MGTABLET / ORALAB2010-10-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090515-002LEVETIRACETAM500MGTABLET / ORALAB2010-10-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090515-003LEVETIRACETAM750MGTABLET / ORALAB2010-10-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090515-004LEVETIRACETAM1GMTABLET / ORALAB2010-10-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090515-001LEVETIRACETAM250MGTABLET / ORALAB2010-10-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090515-002LEVETIRACETAM500MGTABLET / ORALAB2010-10-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090515-003LEVETIRACETAM750MGTABLET / ORALAB2010-10-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090515-004LEVETIRACETAM1GMTABLET / ORALAB2010-10-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090515-001LEVETIRACETAM250MGTABLET / ORALAB2010-10-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A090515-002LEVETIRACETAM500MGTABLET / ORALAB2010-10-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A090515-003LEVETIRACETAM750MGTABLET / ORALAB2010-10-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A090515-004LEVETIRACETAM1GMTABLET / ORALAB2010-10-08d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090515-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090515-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090515-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090515-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090515-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090515-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090515-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090515-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090515-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090515-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090515-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090515-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090515-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090515-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090515-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090515-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090515-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090515-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090515-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090515-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090515-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090515-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090515-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090515-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090515-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090515-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090515-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090515-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090515-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090515-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090515-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090515-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090515-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090515-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090515-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090515-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090515-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090515-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090515-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090515-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Levetiracetam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM500 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311289Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dfc218c5-672a-420a-b59e-2e0b054e99adAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1796-0Levetiracetam30 in 1 BLISTER PACKTABLET, FILM COATED3022
70518-1796-1Levetiracetam60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6022
70518-1796-2Levetiracetam60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6022
70518-1796-3Levetiracetam60 in 1 BLISTER PACKTABLET, FILM COATED6022
70518-1796-4Levetiracetam30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1796LEVETIRACETAM TABLET, FILM COATED [REMEDYREPACK INC.]19Current NDC, Legacy NDC, 5 package rows20250228_dfc218c5-672a-420a-b59e-2e0b054e99ad.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.dfc218c5-672a-420a-b59e-2e0b054e99ad2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090515
application number: ANDA090515
ndc (package): 70518-1796-1
ndc (product): 70518-1796
ndc11 (package): 70518179601
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.ae405796-1eca-4890-bcb2-e1b07654a24d2026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090515
application number: ANDA090515
LevetiracetamLEVETIRACETAMInjecta Medcial LLC52fa0eec-3dd9-59ca-e063-6394a90a97912026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090515
application number: ANDA090515
LevetiracetamLEVETIRACETAMPreferred Pharmaceuticals, Inc.419b3dba-ae21-4268-ac8b-342aaa6095542026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090515
application number: ANDA090515
LEVETIRACETAMLEVETIRACETAMDIRECT RXc3b62114-a590-f4db-e053-2995a90a9d302026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090515
application number: ANDA090515
LevetiracetamLEVETIRACETAMA-S Medication Solutions30f43d3b-c944-4f25-b5d3-0092949449622026-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090515
application number: ANDA090515
LevetiracetamLEVETIRACETAMNorthwind Health Company, LLCfc4c72e2-9cba-88d9-e053-6394a90a04262026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090515
application number: ANDA090515
LevetiracetamLEVETIRACETAMA-S Medication Solutionsb9597cd5-5745-494a-bd72-93071ed221da2025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090515
application number: ANDA090515
LevetiracetamLEVETIRACETAMPD-Rx Pharmaceuticals, Inc.792db8dc-177b-4864-8600-12823819082d2025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090515
application number: ANDA090515
LevetiracetamLEVETIRACETAMQuallent Pharmaceuticals Health LLC3756f052-919c-4817-a56e-1091fd514d9d2025-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090515
application number: ANDA090515
LevetiracetamLEVETIRACETAMNorthStar RxLLC3884cb76-822b-400d-9b24-49c286c9b6f72025-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090515
application number: ANDA090515
LevetiracetamLEVETIRACETAMXLCare Pharmaceuticals Inc.567f09e6-ccd5-4688-a22b-0bc66a5fe31e2024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090515
application number: ANDA090515
LevetiracetamLEVETIRACETAMBryant Ranch Prepackbc8b413f-2f07-4e6a-bb8e-a1f2119ae1cf2024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090515
application number: ANDA090515
LevetiracetamLEVETIRACETAMBryant Ranch Prepackadbcb0f7-0421-47e2-854e-e1cfefb6386f2024-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090515
application number: ANDA090515
LevetiracetamLEVETIRACETAMCamber Pharmaceuticals, Inc.63b36274-89f0-42d8-9f09-f9e78e179af42024-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090515
application number: ANDA090515

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311289levETIRAcetam 500 MG Oral TabletPSNdfc218c5-672a-420a-b59e-2e0b054e99ad22
311289levetiracetam 500 MG Oral TabletSCDdfc218c5-672a-420a-b59e-2e0b054e99ad22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1796-17051817960160 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1796-1) 2020-02-090000-00-00NoNoCurrent