Levetiracetam

Product NDC
16714-034
11-digit product format
167140034
Labeler code
16714
Product ID
16714-034_40911071-2280-bd37-e063-6394a90a0156
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA090515
Marketing category
ANDA
Marketing start
2022-03-29
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

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…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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
ndc (product): 16714-034
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

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
3884cb76-822b-400d-9b24-49c286c9b6f7Available 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
16714-034-01Levetiracetam120 in 1 BOTTLETABLET, FILM COATED1207
16714-034-02Levetiracetam500 in 1 BOTTLETABLET, FILM COATED5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-034-01EA - Each16714-034ef01e077-ce7e-4830-b9e1-b6c1894d0ead12022-06-06
16714-034-02EA - Each16714-0348e7e4706-1848-40d9-9f1c-386d087bfc2912022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-034LEVETIRACETAM (LEVETIRACETAM) TABLET, FILM COATED [NORTHSTAR RXLLC]6Current NDC, Legacy NDC, 2 package rows20240511_3884cb76-822b-400d-9b24-49c286c9b6f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSN3884cb76-822b-400d-9b24-49c286c9b6f77
311288levETIRAcetam 250 MG Oral TabletPSN3884cb76-822b-400d-9b24-49c286c9b6f77
311289levETIRAcetam 500 MG Oral TabletPSN3884cb76-822b-400d-9b24-49c286c9b6f77
311290levETIRAcetam 750 MG Oral TabletPSN3884cb76-822b-400d-9b24-49c286c9b6f77
387003levetiracetam 1000 MG Oral TabletSCD3884cb76-822b-400d-9b24-49c286c9b6f77
311288levetiracetam 250 MG Oral TabletSCD3884cb76-822b-400d-9b24-49c286c9b6f77
311289levetiracetam 500 MG Oral TabletSCD3884cb76-822b-400d-9b24-49c286c9b6f77
311290levetiracetam 750 MG Oral TabletSCD3884cb76-822b-400d-9b24-49c286c9b6f77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-034-0116714003401120 TABLET, FILM COATED in 1 BOTTLE (16714-034-01) 2022-03-290000-00-00NoNoCurrent
16714-034-0216714003402500 TABLET, FILM COATED in 1 BOTTLE (16714-034-02) 2022-03-290000-00-00NoNoCurrent