Levetiracetam

Product NDC
50090-7717
Requested package NDC
50090-7717-0
11-digit product format
500907717
Labeler code
50090
Product ID
50090-7717_453bcdb0-0e8d-46eb-b377-d889c3333d85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090767
Marketing category
ANDA
Marketing start
2024-06-10
Substance
LEVETIRACETAM
Active strength
500 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
A090767-001LEVETIRACETAMLEVETIRACETAM250MGTABLET / ORALAB2010-07-28
A090767-002LEVETIRACETAMLEVETIRACETAM500MGTABLET / ORALAB2010-07-28
A090767-003LEVETIRACETAMLEVETIRACETAM750MGTABLET / ORALAB2010-07-28
A090767-004LEVETIRACETAMLEVETIRACETAM1GMTABLET / ORALAB2010-07-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A090767-001AB
A090767-002AB
A090767-003AB
A090767-004AB

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090767-001LEVETIRACETAM250MGTABLET / ORALAB2010-07-2884e616aacf4f…
2026-09-14 22:38:342026-08A090767-002LEVETIRACETAM500MGTABLET / ORALAB2010-07-2884e616aacf4f…
2026-09-14 22:38:342026-08A090767-003LEVETIRACETAM750MGTABLET / ORALAB2010-07-2884e616aacf4f…
2026-09-14 22:38:342026-08A090767-004LEVETIRACETAM1GMTABLET / ORALAB2010-07-2884e616aacf4f…
2026-08-18 06:07:402026-07A090767-001LEVETIRACETAM250MGTABLET / ORALAB2010-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07A090767-002LEVETIRACETAM500MGTABLET / ORALAB2010-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07A090767-003LEVETIRACETAM750MGTABLET / ORALAB2010-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07A090767-004LEVETIRACETAM1GMTABLET / ORALAB2010-07-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090767-001LEVETIRACETAM250MGTABLET / ORALAB2010-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090767-002LEVETIRACETAM500MGTABLET / ORALAB2010-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090767-003LEVETIRACETAM750MGTABLET / ORALAB2010-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090767-004LEVETIRACETAM1GMTABLET / ORALAB2010-07-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090767-001LEVETIRACETAM250MGTABLET / ORALAB2010-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090767-002LEVETIRACETAM500MGTABLET / ORALAB2010-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090767-003LEVETIRACETAM750MGTABLET / ORALAB2010-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090767-004LEVETIRACETAM1GMTABLET / ORALAB2010-07-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A090767-001LEVETIRACETAM250MGTABLET / ORALAB2010-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090767-002LEVETIRACETAM500MGTABLET / ORALAB2010-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090767-003LEVETIRACETAM750MGTABLET / ORALAB2010-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090767-004LEVETIRACETAM1GMTABLET / ORALAB2010-07-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090767-001LEVETIRACETAM250MGTABLET / ORALAB2010-07-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090767-002LEVETIRACETAM500MGTABLET / ORALAB2010-07-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090767-003LEVETIRACETAM750MGTABLET / ORALAB2010-07-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090767-004LEVETIRACETAM1GMTABLET / ORALAB2010-07-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090767-001LEVETIRACETAM250MGTABLET / ORALAB2010-07-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090767-002LEVETIRACETAM500MGTABLET / ORALAB2010-07-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090767-003LEVETIRACETAM750MGTABLET / ORALAB2010-07-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090767-004LEVETIRACETAM1GMTABLET / ORALAB2010-07-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090767-001LEVETIRACETAM250MGTABLET / ORALAB2010-07-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090767-002LEVETIRACETAM500MGTABLET / ORALAB2010-07-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090767-003LEVETIRACETAM750MGTABLET / ORALAB2010-07-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090767-004LEVETIRACETAM1GMTABLET / ORALAB2010-07-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090767-001LEVETIRACETAM250MGTABLET / ORALAB2010-07-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090767-002LEVETIRACETAM500MGTABLET / ORALAB2010-07-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090767-003LEVETIRACETAM750MGTABLET / ORALAB2010-07-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090767-004LEVETIRACETAM1GMTABLET / ORALAB2010-07-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090767-001LEVETIRACETAM250MGTABLET / ORALAB2010-07-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090767-002LEVETIRACETAM500MGTABLET / ORALAB2010-07-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090767-003LEVETIRACETAM750MGTABLET / ORALAB2010-07-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090767-004LEVETIRACETAM1GMTABLET / ORALAB2010-07-285bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090767-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090767-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A090767-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A090767-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A090767-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090767-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090767-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090767-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090767-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090767-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090767-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090767-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090767-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090767-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090767-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090767-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090767-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090767-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090767-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090767-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090767-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090767-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090767-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090767-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090767-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090767-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090767-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090767-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090767-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090767-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090767-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090767-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090767-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090767-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090767-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090767-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090767-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090767-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090767-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090767-004AB15bbf6a4d5a75…

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
LEVETIRACETAM500 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
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
671a1ae1-f672-48da-8a69-94c147472003Available 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
50090-7717-0Levetiracetam120 in 1 BOTTLETABLET, FILM COATED1201
50090-7717-1Levetiracetam60 in 1 BOTTLETABLET, FILM COATED601
50090-7717-2Levetiracetam90 in 1 BOTTLETABLET, FILM COATED901
50090-7717-3Levetiracetam180 in 1 BOTTLETABLET, FILM COATED1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7717-0EA - Each50090-7717452f41f8-5886-4b0e-8d0c-47bc7ec4f6dd12025-12-16
50090-7717-1EA - Each50090-7717cc9abd9e-279d-4f77-9622-ac7f5157a04612025-12-16
50090-7717-2EA - Each50090-7717f8bfdc4f-08b7-48bf-9e80-12b382a351ec12025-12-16
50090-7717-3EA - Each50090-7717efa395b2-fae6-4b7d-8dc8-04ea9dbd381412025-12-16

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevetiracetamLEVETIRACETAMA-S Medication Solutions671a1ae1-f672-48da-8a69-94c1474720032025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090767
application number: ANDA090767
ndc (package): 50090-7717-0
ndc (product): 50090-7717
ndc11 (package): 50090771700
LevetiracetamLEVETIRACETAMRising Pharma Holdings, Inc.db423b93-d7c2-4cf2-829b-24b657f27f932025-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090767
application number: ANDA090767
LevetiracetamLEVETIRACETAMAmneal Pharmaceuticals LLCd7932a2c-a3b7-46df-a306-1f17716160a02017-11-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090767
application number: ANDA090767

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311289levETIRAcetam 500 MG Oral TabletPSN671a1ae1-f672-48da-8a69-94c1474720031
311289levetiracetam 500 MG Oral TabletSCD671a1ae1-f672-48da-8a69-94c1474720031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7717-050090771700120 TABLET, FILM COATED in 1 BOTTLE (50090-7717-0) 2025-10-15NoNoCurrent