Levetiracetam

Product NDC
43547-881
11-digit product format
435470881
Labeler code
43547
Product ID
43547-881_57f09129-7151-4a75-9d73-9dd32f74ba43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA078106
Marketing category
ANDA
Marketing start
2012-09-11
Substance
LEVETIRACETAM
Active strength
500 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
A078106-001LEVETIRACETAMLEVETIRACETAM250MGTABLET / ORALAB2009-02-10
A078106-002LEVETIRACETAMLEVETIRACETAM500MGTABLET / ORALAB2009-02-10
A078106-003LEVETIRACETAMLEVETIRACETAM750MGTABLET / ORALAB2009-02-10
A078106-004LEVETIRACETAMLEVETIRACETAM1GMTABLET / ORALAB2009-02-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078106-001AB
A078106-002AB
A078106-003AB
A078106-004AB

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 UTC2026-02A078106-001LEVETIRACETAM250MGTABLET / ORALAB2009-02-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078106-002LEVETIRACETAM500MGTABLET / ORALAB2009-02-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078106-003LEVETIRACETAM750MGTABLET / ORALAB2009-02-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078106-004LEVETIRACETAM1GMTABLET / ORALAB2009-02-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078106-001LEVETIRACETAM250MGTABLET / ORALAB2009-02-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078106-002LEVETIRACETAM500MGTABLET / ORALAB2009-02-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078106-003LEVETIRACETAM750MGTABLET / ORALAB2009-02-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078106-004LEVETIRACETAM1GMTABLET / ORALAB2009-02-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A078106-001LEVETIRACETAM250MGTABLET / ORALAB2009-02-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078106-002LEVETIRACETAM500MGTABLET / ORALAB2009-02-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078106-003LEVETIRACETAM750MGTABLET / ORALAB2009-02-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078106-004LEVETIRACETAM1GMTABLET / ORALAB2009-02-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078106-001LEVETIRACETAM250MGTABLET / ORALAB2009-02-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078106-002LEVETIRACETAM500MGTABLET / ORALAB2009-02-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078106-003LEVETIRACETAM750MGTABLET / ORALAB2009-02-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078106-004LEVETIRACETAM1GMTABLET / ORALAB2009-02-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078106-001LEVETIRACETAM250MGTABLET / ORALAB2009-02-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078106-002LEVETIRACETAM500MGTABLET / ORALAB2009-02-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078106-003LEVETIRACETAM750MGTABLET / ORALAB2009-02-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078106-004LEVETIRACETAM1GMTABLET / ORALAB2009-02-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078106-001LEVETIRACETAM250MGTABLET / ORALAB2009-02-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078106-002LEVETIRACETAM500MGTABLET / ORALAB2009-02-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078106-003LEVETIRACETAM750MGTABLET / ORALAB2009-02-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078106-004LEVETIRACETAM1GMTABLET / ORALAB2009-02-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078106-001LEVETIRACETAM250MGTABLET / ORALAB2009-02-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078106-002LEVETIRACETAM500MGTABLET / ORALAB2009-02-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078106-003LEVETIRACETAM750MGTABLET / ORALAB2009-02-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078106-004LEVETIRACETAM1GMTABLET / ORALAB2009-02-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078106-001LEVETIRACETAM250MGTABLET / ORALAB2009-02-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078106-002LEVETIRACETAM500MGTABLET / ORALAB2009-02-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078106-003LEVETIRACETAM750MGTABLET / ORALAB2009-02-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078106-004LEVETIRACETAM1GMTABLET / ORALAB2009-02-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078106-001LEVETIRACETAM250MGTABLET / ORALAB2009-02-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078106-002LEVETIRACETAM500MGTABLET / ORALAB2009-02-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078106-003LEVETIRACETAM750MGTABLET / ORALAB2009-02-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078106-004LEVETIRACETAM1GMTABLET / ORALAB2009-02-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078106-001LEVETIRACETAM250MGTABLET / ORALAB2009-02-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A078106-002LEVETIRACETAM500MGTABLET / ORALAB2009-02-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A078106-003LEVETIRACETAM750MGTABLET / ORALAB2009-02-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A078106-004LEVETIRACETAM1GMTABLET / ORALAB2009-02-10d06236e962d9…

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 UTC2026-02A078106-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078106-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078106-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078106-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078106-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078106-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078106-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078106-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078106-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078106-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078106-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078106-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078106-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078106-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078106-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078106-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078106-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078106-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078106-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078106-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078106-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078106-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078106-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078106-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078106-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078106-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078106-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078106-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078106-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078106-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078106-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078106-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078106-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078106-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078106-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078106-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078106-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078106-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078106-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078106-004AB1d06236e962d9…

Additional Listing Data#

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

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 · 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
57f09129-7151-4a75-9d73-9dd32f74ba43Available 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
43547-881-15Levetiracetam120 in 1 BOTTLETABLET, FILM COATED1201
43547-881-50Levetiracetam500 in 1 BOTTLETABLET, FILM COATED5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-881LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]1Current NDC, 2 package rows20250406_57f09129-7151-4a75-9d73-9dd32f74ba43.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevetiracetamLEVETIRACETAMBryant Ranch Prepacked8e88d0-993e-4683-bdcf-31578130d3df2024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078106
application number: ANDA078106
LevetiracetamLEVETIRACETAMSolco Healthcare US, LLC57f09129-7151-4a75-9d73-9dd32f74ba432024-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078106
application number: ANDA078106
ndc (product): 43547-881
LevetiracetamLEVETIRACETAMSolco Healthcare US, LLCdd713e60-478c-43cd-b680-ff594a0b38642024-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078106
application number: ANDA078106
LevetiracetamLEVETIRACETAMPrinston Pharmaceutical Inc.d818ef84-9b3e-434b-92d9-910cfa8af7da2020-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078106
application number: ANDA078106

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSN57f09129-7151-4a75-9d73-9dd32f74ba431
311288levETIRAcetam 250 MG Oral TabletPSN57f09129-7151-4a75-9d73-9dd32f74ba431
311289levETIRAcetam 500 MG Oral TabletPSN57f09129-7151-4a75-9d73-9dd32f74ba431
311290levETIRAcetam 750 MG Oral TabletPSN57f09129-7151-4a75-9d73-9dd32f74ba431
387003levetiracetam 1000 MG Oral TabletSCD57f09129-7151-4a75-9d73-9dd32f74ba431
311288levetiracetam 250 MG Oral TabletSCD57f09129-7151-4a75-9d73-9dd32f74ba431
311289levetiracetam 500 MG Oral TabletSCD57f09129-7151-4a75-9d73-9dd32f74ba431
311290levetiracetam 750 MG Oral TabletSCD57f09129-7151-4a75-9d73-9dd32f74ba431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43547-881-1543547088115120 TABLET, FILM COATED in 1 BOTTLE (43547-881-15) 2024-09-01NoNoCurrent
43547-881-5043547088150500 TABLET, FILM COATED in 1 BOTTLE (43547-881-50) 2024-09-01NoNoCurrent