Levetiracetam

Product NDC
68084-859
11-digit product format
680840859
Labeler code
68084
Product ID
68084-859_2737b5f9-5127-8b84-e063-6294a90aa140
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA078993
Marketing category
ANDA
Marketing start
2015-02-04
Substance
LEVETIRACETAM
Active strength
250 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 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
A078993-001LEVETIRACETAMLEVETIRACETAM250MGTABLET / ORALAB2009-01-15
A078993-002LEVETIRACETAMLEVETIRACETAM500MGTABLET / ORALAB2009-01-15
A078993-003LEVETIRACETAMLEVETIRACETAM750MGTABLET / ORALAB2009-01-15
A078993-004LEVETIRACETAMLEVETIRACETAM1GMTABLET / ORALAB2009-01-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078993-001AB
A078993-002AB
A078993-003AB
A078993-004AB

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 UTC2026-02A078993-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078993-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078993-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078993-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078993-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078993-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078993-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078993-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078993-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078993-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078993-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078993-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078993-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078993-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078993-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078993-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078993-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078993-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078993-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078993-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078993-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078993-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078993-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078993-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078993-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078993-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078993-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078993-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078993-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078993-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078993-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078993-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078993-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078993-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078993-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078993-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078993-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A078993-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A078993-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A078993-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-15d06236e962d9…

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 UTC2026-02A078993-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078993-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078993-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078993-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078993-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078993-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078993-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078993-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078993-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078993-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078993-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078993-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078993-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078993-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078993-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078993-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078993-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078993-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078993-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078993-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078993-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078993-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078993-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078993-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078993-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078993-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078993-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078993-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078993-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078993-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078993-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078993-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078993-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078993-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078993-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078993-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078993-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078993-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078993-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078993-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Levetiracetam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM250 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311288Internal RxNorm lookup
311290Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fc8bf57e-8aa2-4d3c-856d-b19de65e3ba0Available 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
68084-859-01Levetiracetam100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10010
68084-859-11Levetiracetam1 in 1 BLISTER PACKTABLET, FILM COATED110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-859-01EA - Each68084-8599e33f079-17a1-4117-9097-dbff7a343c6b12015-03-03
68084-859-11EA - Each68084-85926580499-2d22-447b-95d4-d6bf2a14177f12015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
WATERINACTIVE INGREDIENT059QF0KO0RLEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-859LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]10Current NDC, Legacy NDC, 2 package rows20241121_fc8bf57e-8aa2-4d3c-856d-b19de65e3ba0.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
LevetiracetamLEVETIRACETAMUnit Dose Solutions, Inc.551626eb-3282-e439-e063-6294a90a83142026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMCoupler LLC53843871-23e3-974e-e063-6394a90a80422026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMCoupler LLC51b66893-f7d6-8f9d-e063-6294a90a8e9b2026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMCoupler LLC5037a86a-21f2-d793-e063-6394a90a2cb52026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMA-S Medication Solutions6e31e766-6504-4f20-8831-1953363cace02025-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMA-S Medication Solutions01aef7f7-6092-4e39-8451-dc02d8db92542025-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMA-S Medication Solutions58ed7049-44c6-4f97-9174-c0e1504586a62025-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMA-S Medication Solutions5eb7bea5-c95f-4a38-a5bb-c20d1549c7972025-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMA-S Medication Solutionsbc12f0b0-e05c-48e4-ad08-0ff14a818a642025-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMMajor Pharmaceuticalsc4b27429-50a3-467c-a5ff-7e49a01a10882025-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMCardinal Health 107, LLC0348fec4-d919-4307-ac90-35360819bc002025-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMBluePoint Laboratories8b74b8bc-d95c-4471-8f74-c3117243bf892024-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMAmerican Health Packagingfc8bf57e-8aa2-4d3c-856d-b19de65e3ba02024-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
ndc (product): 68084-859
LevetiracetamLEVETIRACETAMAmerican Health Packaging031a32e1-675a-4efe-a66b-40beb4fe51012024-06-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMAurobindo Pharma Limited2471ee03-d747-4113-86d0-1aa93c8f3eba2024-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311288levETIRAcetam 250 MG Oral TabletPSNfc8bf57e-8aa2-4d3c-856d-b19de65e3ba010
311290levETIRAcetam 750 MG Oral TabletPSNfc8bf57e-8aa2-4d3c-856d-b19de65e3ba010
311288levetiracetam 250 MG Oral TabletSCDfc8bf57e-8aa2-4d3c-856d-b19de65e3ba010
311290levetiracetam 750 MG Oral TabletSCDfc8bf57e-8aa2-4d3c-856d-b19de65e3ba010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-859-0168084085901100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-859-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-859-11) 100 blister pack2015-02-040000-00-00NoNoCurrent
68084-859-11680840859111 in 1 BLISTER PACKHistorical