Levetiracetam

Product NDC
66993-100
11-digit product format
669930100
Labeler code
66993
Product ID
66993-100_265f6517-11c1-4af8-9871-ef7fdde464e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levetiracetam
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
Labeler
Prasco Laboratories
Application
NDA207958
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2025-01-20
Substance
LEVETIRACETAM
Active strength
250 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
N207958-001SPRITAMLEVETIRACETAM250MGTABLET, FOR SUSPENSION / ORALRLD2015-07-31
N207958-002SPRITAMLEVETIRACETAM500MGTABLET, FOR SUSPENSION / ORALRLD, RS2015-07-31
N207958-003SPRITAMLEVETIRACETAM750MGTABLET, FOR SUSPENSION / ORALRLD2015-07-31
N207958-004SPRITAMLEVETIRACETAM1GMTABLET, FOR SUSPENSION / ORALRLD2015-07-31

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N207958-001111607862034-03-14Drug product2021-11-30
N207958-00193394892034-03-14U-1850Drug product2017-07-25
N207958-00196690092034-03-14U-18502017-06-28
N207958-00196690092034-03-14U-20212017-06-28
N207958-00196690092034-03-14U-20222017-06-28
N207958-002111607862034-03-14Drug product2021-11-30
N207958-00293394892034-03-14U-1850Drug product2016-06-16
N207958-00296690092034-03-14U-18502017-06-28
N207958-00296690092034-03-14U-20212017-06-28
N207958-00296690092034-03-14U-20222017-06-28
N207958-003111607862034-03-14Drug product2021-11-30
N207958-00393394892034-03-14U-1850Drug product2016-06-16
N207958-00396690092034-03-14U-18502017-06-28
N207958-00396690092034-03-14U-20212017-06-28
N207958-00396690092034-03-14U-20222017-06-28
N207958-004111607862034-03-14Drug product2021-11-30
N207958-00493394892034-03-14U-1850Drug product2016-06-16
N207958-00496690092034-03-14U-18502017-06-28
N207958-00496690092034-03-14U-20212017-06-28
N207958-00496690092034-03-14U-20222017-06-28

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 UTC2026-02N207958-001SPRITAM250MGTABLET, FOR SUSPENSION / ORALRLD2015-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207958-002SPRITAM500MGTABLET, FOR SUSPENSION / ORALRLD, RS2015-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207958-003SPRITAM750MGTABLET, FOR SUSPENSION / ORALRLD2015-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207958-004SPRITAM1GMTABLET, FOR SUSPENSION / ORALRLD2015-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-001SPRITAM250MGTABLET, FOR SUSPENSION / ORALRLD2015-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-002SPRITAM500MGTABLET, FOR SUSPENSION / ORALRLD, RS2015-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-003SPRITAM750MGTABLET, FOR SUSPENSION / ORALRLD2015-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-004SPRITAM1GMTABLET, FOR SUSPENSION / ORALRLD2015-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N207958-001SPRITAM250MGTABLET, FOR SUSPENSION / ORALRLD2015-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207958-002SPRITAM500MGTABLET, FOR SUSPENSION / ORALRLD, RS2015-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207958-003SPRITAM750MGTABLET, FOR SUSPENSION / ORALRLD2015-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207958-004SPRITAM1GMTABLET, FOR SUSPENSION / ORALRLD2015-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207958-001SPRITAM250MGTABLET, FOR SUSPENSION / ORALRLD2015-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207958-002SPRITAM500MGTABLET, FOR SUSPENSION / ORALRLD2015-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207958-003SPRITAM750MGTABLET, FOR SUSPENSION / ORALRLD2015-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207958-004SPRITAM1GMTABLET, FOR SUSPENSION / ORALRLD, RS2015-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207958-001SPRITAM250MGTABLET, FOR SUSPENSION / ORALRLD2015-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207958-002SPRITAM500MGTABLET, FOR SUSPENSION / ORALRLD2015-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207958-003SPRITAM750MGTABLET, FOR SUSPENSION / ORALRLD2015-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207958-004SPRITAM1GMTABLET, FOR SUSPENSION / ORALRLD, RS2015-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207958-001SPRITAM250MGTABLET, FOR SUSPENSION / ORALRLD2015-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207958-002SPRITAM500MGTABLET, FOR SUSPENSION / ORALRLD2015-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207958-003SPRITAM750MGTABLET, FOR SUSPENSION / ORALRLD2015-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207958-004SPRITAM1GMTABLET, FOR SUSPENSION / ORALRLD, RS2015-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207958-001SPRITAM250MGTABLET, FOR SUSPENSION / ORALRLD2015-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207958-002SPRITAM500MGTABLET, FOR SUSPENSION / ORALRLD2015-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207958-003SPRITAM750MGTABLET, FOR SUSPENSION / ORALRLD2015-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207958-004SPRITAM1GMTABLET, FOR SUSPENSION / ORALRLD, RS2015-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207958-001SPRITAM250MGTABLET, FOR SUSPENSION / ORALRLD2015-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207958-002SPRITAM500MGTABLET, FOR SUSPENSION / ORALRLD2015-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207958-003SPRITAM750MGTABLET, FOR SUSPENSION / ORALRLD2015-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207958-004SPRITAM1GMTABLET, FOR SUSPENSION / ORALRLD, RS2015-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207958-001SPRITAM250MGTABLET, FOR SUSPENSION / ORALRLD2015-07-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207958-002SPRITAM500MGTABLET, FOR SUSPENSION / ORALRLD2015-07-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207958-003SPRITAM750MGTABLET, FOR SUSPENSION / ORALRLD2015-07-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207958-004SPRITAM1GMTABLET, FOR SUSPENSION / ORALRLD, RS2015-07-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N207958-001SPRITAM250MGTABLET, FOR SUSPENSION / ORALRLD2015-07-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N207958-002SPRITAM500MGTABLET, FOR SUSPENSION / ORALRLD2015-07-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N207958-003SPRITAM750MGTABLET, FOR SUSPENSION / ORALRLD2015-07-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N207958-004SPRITAM1GMTABLET, FOR SUSPENSION / ORALRLD, RS2015-07-31d06236e962d9…

Observed Orange Book patent history#

Patent history page 1 of 20 · 788 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N207958-001111607862034-03-14Drug product2021-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207958-00193394892034-03-14U-1850Drug product2017-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207958-00196690092034-03-14U-20212017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207958-00196690092034-03-14U-20222017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207958-00196690092034-03-14U-18502017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207958-002111607862034-03-14Drug product2021-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207958-00293394892034-03-14U-1850Drug product2016-06-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207958-00296690092034-03-14U-18502017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207958-00296690092034-03-14U-20222017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207958-00296690092034-03-14U-20212017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207958-003111607862034-03-14Drug product2021-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207958-00393394892034-03-14U-1850Drug product2016-06-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207958-00396690092034-03-14U-20212017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207958-00396690092034-03-14U-20222017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207958-00396690092034-03-14U-18502017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207958-004111607862034-03-14Drug product2021-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207958-00493394892034-03-14U-1850Drug product2016-06-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207958-00496690092034-03-14U-18502017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207958-00496690092034-03-14U-20212017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207958-00496690092034-03-14U-20222017-06-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-001111607862034-03-14Drug product2021-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-00193394892034-03-14U-1850Drug product2017-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-00196690092034-03-14U-20212017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-00196690092034-03-14U-20222017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-00196690092034-03-14U-18502017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-002111607862034-03-14Drug product2021-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-00293394892034-03-14U-1850Drug product2016-06-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-00296690092034-03-14U-18502017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-00296690092034-03-14U-20222017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-00296690092034-03-14U-20212017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-003111607862034-03-14Drug product2021-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-00393394892034-03-14U-1850Drug product2016-06-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-00396690092034-03-14U-20212017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-00396690092034-03-14U-20222017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-00396690092034-03-14U-18502017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-004111607862034-03-14Drug product2021-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-00493394892034-03-14U-1850Drug product2016-06-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-00496690092034-03-14U-18502017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-00496690092034-03-14U-20212017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207958-00496690092034-03-14U-20222017-06-2831067a03dcf5…

Additional Listing Data#

Finished product
Yes
Brand name base
Levetiracetam
Listing expiration
2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1736045Internal RxNorm lookup
1736048Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dd175fa3-1d7a-4542-affd-988ac5bba1dbAvailable 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
66993-100-06Levetiracetam6 in 1 CARTONTABLET, FOR SUSPENSION63
66993-100-51Levetiracetam1 in 1 BLISTER PACKTABLET, FOR SUSPENSION13
66993-100-60Levetiracetam60 in 1 CARTONTABLET, FOR SUSPENSION603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-100-06EA - Each66993-10079aa084a-496f-404d-b4f1-425912f6019712025-02-10
66993-100-51EA - Each66993-100b10601cd-633b-4959-86b8-94e176aa46e912025-02-10
66993-100-60EA - Each66993-10037281056-0a7a-4939-be25-90039e84e2d312026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-100LEVETIRACETAM TABLET, FOR SUSPENSION [PRASCO LABORATORIES]2Current NDC, 3 package rows20250120_dd175fa3-1d7a-4542-affd-988ac5bba1db.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SpritamLEVETIRACETAMAprecia Pharmaceuticals, LLCbe651c31-383f-11e4-916c-0800200c9a662025-10-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 207958
application number: NDA207958
LevetiracetamLEVETIRACETAMPrasco Laboratoriesdd175fa3-1d7a-4542-affd-988ac5bba1db2025-07-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 207958
application number: NDA207958
ndc (product): 66993-100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736045levETIRAcetam 250 MG Tablet for Oral SuspensionPSNdd175fa3-1d7a-4542-affd-988ac5bba1db3
1736048levETIRAcetam 500 MG Tablet for Oral SuspensionPSNdd175fa3-1d7a-4542-affd-988ac5bba1db3
1736045levetiracetam 250 MG Tablet for Oral SuspensionSCDdd175fa3-1d7a-4542-affd-988ac5bba1db3
1736048levetiracetam 500 MG Tablet for Oral SuspensionSCDdd175fa3-1d7a-4542-affd-988ac5bba1db3
1736045levetiracetam 250 MG Tablet for Oral SuspensionSYdd175fa3-1d7a-4542-affd-988ac5bba1db3
1736048levetiracetam 500 MG Tablet for Oral SuspensionSYdd175fa3-1d7a-4542-affd-988ac5bba1db3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66993-100-06669930100066 BLISTER PACK in 1 CARTON (66993-100-06) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66993-100-51) 6 blister pack2025-01-20NoNoCurrent
66993-100-51669930100511 in 1 BLISTER PACKHistorical
66993-100-606699301006060 BLISTER PACK in 1 CARTON (66993-100-60) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66993-100-51) 60 blister pack2026-01-16NoNoCurrent