Levetiracetam

Product NDC
76494-528
Requested package NDC
76494-528-12
11-digit product format
764940528
Labeler code
76494
Product ID
76494-528_bf716ab6-d438-4a19-8193-dbc05b4eabad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Prinston Pharmaceutical Inc.
Application
ANDA078106
Marketing category
ANDA
Marketing start
2012-09-11
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

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage76494-52876494-528-12IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage76494-52876494-528-12EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
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
d818ef84-9b3e-434b-92d9-910cfa8af7daAvailable 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76494-528-12Levetiracetam120 in 1 BOTTLETABLET, FILM COATED12012

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KLEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NLEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IELEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
POLYETHYLENE GLYCOL 800INACTIVE INGREDIENTUH6KR4953DLEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
POVIDONESINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
TRIACETININACTIVE INGREDIENTXHX3C3X673LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76494-528LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]12Current NDC, Legacy NDC, 1 package rows20200826_d818ef84-9b3e-434b-92d9-910cfa8af7da.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
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
ndc (package): 76494-528-12
ndc (product): 76494-528
ndc11 (package): 76494052812

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSNd818ef84-9b3e-434b-92d9-910cfa8af7da12
311288levETIRAcetam 250 MG Oral TabletPSNd818ef84-9b3e-434b-92d9-910cfa8af7da12
311289levETIRAcetam 500 MG Oral TabletPSNd818ef84-9b3e-434b-92d9-910cfa8af7da12
311290levETIRAcetam 750 MG Oral TabletPSNd818ef84-9b3e-434b-92d9-910cfa8af7da12
387003levetiracetam 1000 MG Oral TabletSCDd818ef84-9b3e-434b-92d9-910cfa8af7da12
311288levetiracetam 250 MG Oral TabletSCDd818ef84-9b3e-434b-92d9-910cfa8af7da12
311289levetiracetam 500 MG Oral TabletSCDd818ef84-9b3e-434b-92d9-910cfa8af7da12
311290levetiracetam 750 MG Oral TabletSCDd818ef84-9b3e-434b-92d9-910cfa8af7da12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76494-528-1276494052812120 TABLET, FILM COATED in 1 BOTTLE (76494-528-12) 2012-09-110000-00-00NoNoCurrent