Levetiracetam

Product NDC
70010-523
Requested package NDC
70010-523-10
11-digit product format
700100523
Labeler code
70010
Product ID
70010-523_451c385c-1c8a-5eca-e063-6294a90a3a4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA217878
Marketing category
ANDA
Marketing start
2024-06-24
Substance
LEVETIRACETAM
Active strength
750 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
A217878-001LEVETIRACETAMLEVETIRACETAM250MGTABLET / ORAL2023-06-13
A217878-002LEVETIRACETAMLEVETIRACETAM500MGTABLET / ORAL2023-06-13
A217878-003LEVETIRACETAMLEVETIRACETAM750MGTABLET / ORAL2023-06-13
A217878-004LEVETIRACETAMLEVETIRACETAM1GMTABLET / ORAL2023-06-13

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 3 · 92 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A217878-001LEVETIRACETAM250MGTABLET / ORAL2023-06-1384e616aacf4f…
2026-09-14 22:38:342026-08A217878-002LEVETIRACETAM500MGTABLET / ORAL2023-06-1384e616aacf4f…
2026-09-14 22:38:342026-08A217878-003LEVETIRACETAM750MGTABLET / ORAL2023-06-1384e616aacf4f…
2026-09-14 22:38:342026-08A217878-004LEVETIRACETAM1GMTABLET / ORAL2023-06-1384e616aacf4f…
2026-08-18 06:07:402026-07A217878-001LEVETIRACETAM250MGTABLET / ORAL2023-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07A217878-002LEVETIRACETAM500MGTABLET / ORAL2023-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07A217878-003LEVETIRACETAM750MGTABLET / ORAL2023-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07A217878-004LEVETIRACETAM1GMTABLET / ORAL2023-06-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217878-001LEVETIRACETAM250MGTABLET / ORAL2023-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217878-002LEVETIRACETAM500MGTABLET / ORAL2023-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217878-003LEVETIRACETAM750MGTABLET / ORAL2023-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217878-004LEVETIRACETAM1GMTABLET / ORAL2023-06-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217878-001LEVETIRACETAM250MGTABLET / ORAL2023-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217878-002LEVETIRACETAM500MGTABLET / ORAL2023-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217878-003LEVETIRACETAM750MGTABLET / ORAL2023-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217878-004LEVETIRACETAM1GMTABLET / ORAL2023-06-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A217878-001LEVETIRACETAM250MGTABLET / ORAL2023-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217878-002LEVETIRACETAM500MGTABLET / ORAL2023-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217878-003LEVETIRACETAM750MGTABLET / ORAL2023-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217878-004LEVETIRACETAM1GMTABLET / ORAL2023-06-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217878-001LEVETIRACETAM250MGTABLET / ORAL2023-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217878-002LEVETIRACETAM500MGTABLET / ORAL2023-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217878-003LEVETIRACETAM750MGTABLET / ORAL2023-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217878-004LEVETIRACETAM1GMTABLET / ORAL2023-06-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217878-001LEVETIRACETAM250MGTABLET / ORAL2023-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217878-002LEVETIRACETAM500MGTABLET / ORAL2023-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217878-003LEVETIRACETAM750MGTABLET / ORAL2023-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217878-004LEVETIRACETAM1GMTABLET / ORAL2023-06-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217878-001LEVETIRACETAM250MGTABLET / ORAL2023-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217878-002LEVETIRACETAM500MGTABLET / ORAL2023-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217878-003LEVETIRACETAM750MGTABLET / ORAL2023-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217878-004LEVETIRACETAM1GMTABLET / ORAL2023-06-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217878-001LEVETIRACETAM250MGTABLET / ORAL2023-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217878-002LEVETIRACETAM500MGTABLET / ORAL2023-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217878-003LEVETIRACETAM750MGTABLET / ORAL2023-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217878-004LEVETIRACETAM1GMTABLET / ORAL2023-06-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217878-001LEVETIRACETAM250MGTABLET / ORAL2023-06-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217878-002LEVETIRACETAM500MGTABLET / ORAL2023-06-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217878-003LEVETIRACETAM750MGTABLET / ORAL2023-06-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217878-004LEVETIRACETAM1GMTABLET / ORAL2023-06-135bbf6a4d5a75…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217878-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217878-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217878-003AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217878-004AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217878-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217878-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217878-003AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217878-004AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217878-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A217878-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A217878-003AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A217878-004AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217878-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217878-002AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217878-003AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217878-004AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217878-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217878-002AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217878-003AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217878-004AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A217878-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A217878-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A217878-003AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A217878-004AB1a67488948f0b…

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
LEVETIRACETAM750 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
b4781ec4-43ad-4052-9a6a-b24fda119b32Available 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
70010-523-03Levetiracetam30 in 1 BOTTLETABLET, FILM COATED304
70010-523-10Levetiracetam1000 in 1 BOTTLETABLET, FILM COATED10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-523LEVETIRACETAM TABLET, FILM COATED [GRANULES PHARMACEUTICALS INC.]3Current NDC, 2 package rows20240624_b4781ec4-43ad-4052-9a6a-b24fda119b32.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevetiracetamLEVETIRACETAMGranules Pharmaceuticals Inc.b4781ec4-43ad-4052-9a6a-b24fda119b322025-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217878
application number: ANDA217878
ndc (package): 70010-523-10
ndc (product): 70010-523
ndc11 (package): 70010052310

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSNb4781ec4-43ad-4052-9a6a-b24fda119b324
311288levETIRAcetam 250 MG Oral TabletPSNb4781ec4-43ad-4052-9a6a-b24fda119b324
311289levETIRAcetam 500 MG Oral TabletPSNb4781ec4-43ad-4052-9a6a-b24fda119b324
311290levETIRAcetam 750 MG Oral TabletPSNb4781ec4-43ad-4052-9a6a-b24fda119b324
387003levetiracetam 1000 MG Oral TabletSCDb4781ec4-43ad-4052-9a6a-b24fda119b324
311288levetiracetam 250 MG Oral TabletSCDb4781ec4-43ad-4052-9a6a-b24fda119b324
311289levetiracetam 500 MG Oral TabletSCDb4781ec4-43ad-4052-9a6a-b24fda119b324
311290levetiracetam 750 MG Oral TabletSCDb4781ec4-43ad-4052-9a6a-b24fda119b324

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70010-523-10700100523101000 TABLET, FILM COATED in 1 BOTTLE (70010-523-10) 2024-06-24NoNoCurrent