LEVETIRACETAM

Product NDC
72189-190
Requested package NDC
72189-190-60
11-digit product format
721890190
Labeler code
72189
Product ID
72189-190_4c4bd407-ac66-f594-e063-6294a90a31fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090515
Marketing category
ANDA
Marketing start
2021-06-07
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

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 · 1 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
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-19072189-190-60UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
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
311288Internal RxNorm lookup
311289Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c3b62114-a590-f4db-e053-2995a90a9d30Available 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
72189-190-30LEVETIRACETAM30 in 1 BOTTLETABLET, FILM COATED308
72189-190-60LEVETIRACETAM60 in 1 BOTTLETABLET, FILM COATED608
72189-190-72LEVETIRACETAM120 in 1 BOTTLETABLET, FILM COATED1208
72189-190-90LEVETIRACETAM90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-190-30EA - Each72189-1908149ec9a-a1be-4c98-ae84-5d105998907512021-07-15
72189-190-60EA - Each72189-190da68fc38-6d7f-47e0-b321-9a69b4e1ea4b12022-04-06
72189-190-90EA - Each72189-1904514d095-8871-4c8e-8ef9-90917393f01512023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-190LEVETIRACETAM TABLET, FILM COATED [DIRECT RX]7Current NDC, Legacy NDC, 4 package rows20250425_c3b62114-a590-f4db-e053-2995a90a9d30.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
ndc (package): 72189-190-60
ndc (product): 72189-190
ndc11 (package): 72189019060
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
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
311288levETIRAcetam 250 MG Oral TabletPSNc3b62114-a590-f4db-e053-2995a90a9d308
311289levETIRAcetam 500 MG Oral TabletPSNc3b62114-a590-f4db-e053-2995a90a9d308
311288levetiracetam 250 MG Oral TabletSCDc3b62114-a590-f4db-e053-2995a90a9d308
311289levetiracetam 500 MG Oral TabletSCDc3b62114-a590-f4db-e053-2995a90a9d308

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-190-607218901906060 TABLET, FILM COATED in 1 BOTTLE (72189-190-60) 2021-06-070000-00-00NoNoCurrent