FDA.reportPublic FDA data

Levetiracetam

Product NDC
67877-768
11-digit product format
678770768
Labeler code
67877
Product ID
67877-768_40d1180e-73b5-4e73-8d42-15b99313496f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA216375
Marketing category
ANDA
Marketing start
2022-05-28
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
A216375-001LEVETIRACETAMLEVETIRACETAM250MGTABLET / ORALAB2022-05-27
A216375-002LEVETIRACETAMLEVETIRACETAM500MGTABLET / ORALAB2022-05-27
A216375-003LEVETIRACETAMLEVETIRACETAM750MGTABLET / ORALAB2022-05-27
A216375-004LEVETIRACETAMLEVETIRACETAM1GMTABLET / ORALAB2022-05-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216375-001AB
A216375-002AB
A216375-003AB
A216375-004AB

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 3 · 116 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216375-001LEVETIRACETAM250MGTABLET / ORALAB2022-05-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216375-002LEVETIRACETAM500MGTABLET / ORALAB2022-05-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216375-003LEVETIRACETAM750MGTABLET / ORALAB2022-05-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216375-004LEVETIRACETAM1GMTABLET / ORALAB2022-05-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216375-001LEVETIRACETAM250MGTABLET / ORALAB2022-05-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216375-002LEVETIRACETAM500MGTABLET / ORALAB2022-05-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216375-003LEVETIRACETAM750MGTABLET / ORALAB2022-05-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216375-004LEVETIRACETAM1GMTABLET / ORALAB2022-05-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A216375-001LEVETIRACETAM250MGTABLET / ORALAB2022-05-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216375-002LEVETIRACETAM500MGTABLET / ORALAB2022-05-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216375-003LEVETIRACETAM750MGTABLET / ORALAB2022-05-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216375-004LEVETIRACETAM1GMTABLET / ORALAB2022-05-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216375-001LEVETIRACETAM250MGTABLET / ORALAB2022-05-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216375-002LEVETIRACETAM500MGTABLET / ORALAB2022-05-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216375-003LEVETIRACETAM750MGTABLET / ORALAB2022-05-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216375-004LEVETIRACETAM1GMTABLET / ORALAB2022-05-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216375-001LEVETIRACETAM250MGTABLET / ORALAB2022-05-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216375-002LEVETIRACETAM500MGTABLET / ORALAB2022-05-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216375-003LEVETIRACETAM750MGTABLET / ORALAB2022-05-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216375-004LEVETIRACETAM1GMTABLET / ORALAB2022-05-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216375-001LEVETIRACETAM250MGTABLET / ORALAB2022-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216375-002LEVETIRACETAM500MGTABLET / ORALAB2022-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216375-003LEVETIRACETAM750MGTABLET / ORALAB2022-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216375-004LEVETIRACETAM1GMTABLET / ORALAB2022-05-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216375-001LEVETIRACETAM250MGTABLET / ORALAB2022-05-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216375-002LEVETIRACETAM500MGTABLET / ORALAB2022-05-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216375-003LEVETIRACETAM750MGTABLET / ORALAB2022-05-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216375-004LEVETIRACETAM1GMTABLET / ORALAB2022-05-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216375-001LEVETIRACETAM250MGTABLET / ORALAB2022-05-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216375-002LEVETIRACETAM500MGTABLET / ORALAB2022-05-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216375-003LEVETIRACETAM750MGTABLET / ORALAB2022-05-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216375-004LEVETIRACETAM1GMTABLET / ORALAB2022-05-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216375-001LEVETIRACETAM250MGTABLET / ORALAB2022-05-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216375-002LEVETIRACETAM500MGTABLET / ORALAB2022-05-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216375-003LEVETIRACETAM750MGTABLET / ORALAB2022-05-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216375-004LEVETIRACETAM1GMTABLET / ORALAB2022-05-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216375-001LEVETIRACETAM250MGTABLET / ORALAB2022-05-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A216375-002LEVETIRACETAM500MGTABLET / ORALAB2022-05-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A216375-003LEVETIRACETAM750MGTABLET / ORALAB2022-05-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A216375-004LEVETIRACETAM1GMTABLET / ORALAB2022-05-27d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 116 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216375-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216375-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216375-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216375-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216375-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216375-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216375-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216375-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216375-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216375-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216375-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216375-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216375-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216375-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216375-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216375-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216375-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216375-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216375-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216375-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216375-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216375-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216375-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216375-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216375-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216375-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216375-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216375-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216375-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216375-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216375-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216375-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216375-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216375-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216375-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216375-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216375-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A216375-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A216375-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A216375-004AB1d06236e962d9…

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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311288Internal RxNorm lookup
311289Internal RxNorm lookup
311290Internal RxNorm lookup
387003Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
591dd9f1-3681-4b2f-b096-7536826e3648Available 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
67877-768-05Levetiracetam500 in 1 BOTTLETABLET, FILM COATED50013
67877-768-12Levetiracetam120 in 1 BOTTLETABLET, FILM COATED12013
67877-768-30Levetiracetam30 in 1 BOTTLETABLET, FILM COATED3013
67877-768-33Levetiracetam10 in 1 BLISTER PACKTABLET, FILM COATED1013
67877-768-33Levetiracetam1 in 1 CARTONTABLET, FILM COATED113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-768-05EA - Each67877-768a677cac6-9a79-4b0e-8daf-a1e4c2f2462112022-09-12
67877-768-12EA - Each67877-768039476bd-f58d-443b-8fda-f22a48194e5312022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-768LEVETIRACETAM TABLET, FILM COATED [ASCEND LABORATORIES, LLC]13Current NDC, Legacy NDC, 5 package rows20241115_591dd9f1-3681-4b2f-b096-7536826e3648.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
LevetiracetamLEVETIRACETAMAscend Laboratories, LLC591dd9f1-3681-4b2f-b096-7536826e36482024-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216375
application number: ANDA216375
ndc (product): 67877-768

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSN591dd9f1-3681-4b2f-b096-7536826e364813
311288levETIRAcetam 250 MG Oral TabletPSN591dd9f1-3681-4b2f-b096-7536826e364813
311289levETIRAcetam 500 MG Oral TabletPSN591dd9f1-3681-4b2f-b096-7536826e364813
311290levETIRAcetam 750 MG Oral TabletPSN591dd9f1-3681-4b2f-b096-7536826e364813
387003levetiracetam 1000 MG Oral TabletSCD591dd9f1-3681-4b2f-b096-7536826e364813
311288levetiracetam 250 MG Oral TabletSCD591dd9f1-3681-4b2f-b096-7536826e364813
311289levetiracetam 500 MG Oral TabletSCD591dd9f1-3681-4b2f-b096-7536826e364813
311290levetiracetam 750 MG Oral TabletSCD591dd9f1-3681-4b2f-b096-7536826e364813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-768-0567877076805500 TABLET, FILM COATED in 1 BOTTLE (67877-768-05) 2022-05-280000-00-00NoNoCurrent
67877-768-1267877076812120 TABLET, FILM COATED in 1 BOTTLE (67877-768-12) 2022-05-280000-00-00NoNoCurrent
67877-768-306787707683030 TABLET, FILM COATED in 1 BOTTLE (67877-768-30) 2022-05-280000-00-00NoNoCurrent
67877-768-33678770768331 BLISTER PACK in 1 CARTON (67877-768-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2022-05-280000-00-00NoNoCurrent