Levetiracetam

Product NDC
50090-7333
11-digit product format
500907333
Labeler code
50090
Product ID
50090-7333_e912f362-a9eb-47aa-a9f5-261deee63d79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA215069
Marketing category
ANDA
Marketing start
2021-06-11
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A215069-001LEVETIRACETAMLEVETIRACETAM750MGTABLET / ORALAB2021-06-11
A215069-002LEVETIRACETAMLEVETIRACETAM1GMTABLET / ORALAB2021-06-11
A215069-003LEVETIRACETAMLEVETIRACETAM250MGTABLET / ORALAB2022-05-27
A215069-004LEVETIRACETAMLEVETIRACETAM500MGTABLET / 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
A215069-001AB
A215069-002AB
A215069-003AB
A215069-004AB

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 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A215069-001LEVETIRACETAM750MGTABLET / ORALAB2021-06-1184e616aacf4f…
2026-09-14 22:38:342026-08A215069-002LEVETIRACETAM1GMTABLET / ORALAB2021-06-1184e616aacf4f…
2026-09-14 22:38:342026-08A215069-003LEVETIRACETAM250MGTABLET / ORALAB2022-05-2784e616aacf4f…
2026-09-14 22:38:342026-08A215069-004LEVETIRACETAM500MGTABLET / ORALAB2022-05-2784e616aacf4f…
2026-08-18 06:07:402026-07A215069-001LEVETIRACETAM750MGTABLET / ORALAB2021-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07A215069-002LEVETIRACETAM1GMTABLET / ORALAB2021-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07A215069-003LEVETIRACETAM250MGTABLET / ORALAB2022-05-27caaa826d4ba7…
2026-08-18 06:07:402026-07A215069-004LEVETIRACETAM500MGTABLET / ORALAB2022-05-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215069-001LEVETIRACETAM750MGTABLET / ORALAB2021-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215069-002LEVETIRACETAM1GMTABLET / ORALAB2021-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215069-003LEVETIRACETAM250MGTABLET / ORALAB2022-05-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215069-004LEVETIRACETAM500MGTABLET / ORALAB2022-05-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215069-001LEVETIRACETAM750MGTABLET / ORALAB2021-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215069-002LEVETIRACETAM1GMTABLET / ORALAB2021-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215069-003LEVETIRACETAM250MGTABLET / ORALAB2022-05-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215069-004LEVETIRACETAM500MGTABLET / ORALAB2022-05-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A215069-001LEVETIRACETAM750MGTABLET / ORALAB2021-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215069-002LEVETIRACETAM1GMTABLET / ORALAB2021-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215069-003LEVETIRACETAM250MGTABLET / ORALAB2022-05-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215069-004LEVETIRACETAM500MGTABLET / ORALAB2022-05-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215069-001LEVETIRACETAM750MGTABLET / ORALAB2021-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215069-002LEVETIRACETAM1GMTABLET / ORALAB2021-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215069-003LEVETIRACETAM250MGTABLET / ORALAB2022-05-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215069-004LEVETIRACETAM500MGTABLET / ORALAB2022-05-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215069-001LEVETIRACETAM750MGTABLET / ORALAB2021-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215069-002LEVETIRACETAM1GMTABLET / ORALAB2021-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215069-003LEVETIRACETAM250MGTABLET / ORALAB2022-05-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215069-004LEVETIRACETAM500MGTABLET / ORALAB2022-05-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215069-001LEVETIRACETAM750MGTABLET / ORALAB2021-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215069-002LEVETIRACETAM1GMTABLET / ORALAB2021-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215069-003LEVETIRACETAM250MGTABLET / ORALAB2022-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215069-004LEVETIRACETAM500MGTABLET / ORALAB2022-05-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215069-001LEVETIRACETAM750MGTABLET / ORALAB2021-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215069-002LEVETIRACETAM1GMTABLET / ORALAB2021-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215069-003LEVETIRACETAM250MGTABLET / ORALAB2022-05-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215069-004LEVETIRACETAM500MGTABLET / ORALAB2022-05-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215069-001LEVETIRACETAM750MGTABLET / ORALAB2021-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215069-002LEVETIRACETAM1GMTABLET / ORALAB2021-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215069-003LEVETIRACETAM250MGTABLET / ORALAB2022-05-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215069-004LEVETIRACETAM500MGTABLET / ORALAB2022-05-275bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 130 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A215069-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A215069-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A215069-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A215069-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A215069-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215069-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215069-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215069-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215069-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215069-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215069-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215069-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215069-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215069-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215069-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215069-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215069-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215069-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215069-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215069-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215069-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215069-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215069-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215069-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215069-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215069-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215069-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215069-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215069-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215069-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215069-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215069-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215069-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215069-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215069-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215069-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215069-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215069-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215069-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215069-004AB15bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
8a8472dc-b97e-445d-bf51-b6e618cae1b6Available 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
50090-7333-1Levetiracetam60 in 1 BOTTLETABLET, FILM COATED602
50090-7333-2Levetiracetam180 in 1 BOTTLETABLET, FILM COATED1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7333-1EA - Each50090-7333f1b760f5-397a-4d3b-98b4-b604a8dd8b6d12024-11-05
50090-7333-2EA - Each50090-733330a420bf-cf0e-4c77-90d8-9ec201d21f8f12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7333LEVETIRACETAM (LEVETIRACETAM) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]2Current NDC, 2 package rows20241023_8a8472dc-b97e-445d-bf51-b6e618cae1b6.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
LevetiracetamLEVETIRACETAMA-S Medication Solutionsc3daf220-9741-41c4-b89d-e06cee36dac62025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215069
application number: ANDA215069
LevetiracetamLEVETIRACETAMCoupler LLC43df4156-0958-e496-e063-6294a90a53292025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215069
application number: ANDA215069
LevetiracetamLEVETIRACETAMA-S Medication Solutions8a8472dc-b97e-445d-bf51-b6e618cae1b62024-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215069
application number: ANDA215069
ndc (product): 50090-7333
LevetiracetamLEVETIRACETAMScieGen Pharmaceuticals, Inc.1d71212b-ac97-4a61-8192-8e83035400192024-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215069
application number: ANDA215069

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSN8a8472dc-b97e-445d-bf51-b6e618cae1b62
387003levetiracetam 1000 MG Oral TabletSCD8a8472dc-b97e-445d-bf51-b6e618cae1b62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7333-15009073330160 TABLET, FILM COATED in 1 BOTTLE (50090-7333-1) 2024-10-15NoNoCurrent
50090-7333-250090733302180 TABLET, FILM COATED in 1 BOTTLE (50090-7333-2) 2024-10-15NoNoCurrent