Levetiracetam

Product NDC
50090-2875
Requested package NDC
50090-2875-1
11-digit product format
500902875
Labeler code
50090
Product ID
50090-2875_b9dfd326-74eb-49b7-bfdf-0d3364623536
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090515
Marketing category
ANDA
Marketing start
2010-10-08
Substance
LEVETIRACETAM
Active strength
1000 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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-08-27 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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM1000 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
311289Internal 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
b9597cd5-5745-494a-bd72-93071ed221daAvailable 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
50090-2875-0Levetiracetam30 in 1 BOTTLETABLET, FILM COATED3036
50090-2875-1Levetiracetam60 in 1 BOTTLETABLET, FILM COATED6036
50090-2875-2Levetiracetam180 in 1 BOTTLETABLET, FILM COATED18036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2875-0EA - Each50090-28758914d721-56e6-4e93-9a13-bc010ec1812f12019-04-11
50090-2875-1EA - Each50090-2875d5f7ec99-2eb4-4017-9ae9-80f6d29f247512022-12-07
50090-2875-2EA - Each50090-2875405b09b5-1f84-4b34-91b0-c5bfd0e3538d12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2875LEVETIRACETAM (LEVETIRACETAM) TABLET, FILM COATED LEVETIRACETAM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]33Current NDC, Legacy NDC, 3 package rows20250516_b9597cd5-5745-494a-bd72-93071ed221da.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
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
ndc (package): 50090-2875-1
ndc (product): 50090-2875
ndc11 (package): 50090287501
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
387003levETIRAcetam 1000 MG Oral TabletPSNb9597cd5-5745-494a-bd72-93071ed221da36
311289levETIRAcetam 500 MG Oral TabletPSNb9597cd5-5745-494a-bd72-93071ed221da36
387003levetiracetam 1000 MG Oral TabletSCDb9597cd5-5745-494a-bd72-93071ed221da36
311289levetiracetam 500 MG Oral TabletSCDb9597cd5-5745-494a-bd72-93071ed221da36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2875-15009028750160 TABLET, FILM COATED in 1 BOTTLE (50090-2875-1) 2022-03-150000-00-00NoNoCurrent