Levetiracetam

Product NDC
60505-3280
11-digit product format
605053280
Labeler code
60505
Product ID
60505-3280_24652d3c-86ad-7b6e-6a54-d0a6f952c913
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA091261
Marketing category
ANDA
Marketing start
2011-09-12
Substance
LEVETIRACETAM
Active strength
500 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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091261-001LEVETIRACETAMLEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12
A091261-002LEVETIRACETAMLEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A091261-001AB
A091261-002AB

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091261-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-1284e616aacf4f…
2026-09-14 22:38:342026-08A091261-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-1284e616aacf4f…
2026-08-18 06:07:402026-07A091261-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12caaa826d4ba7…
2026-08-18 06:07:402026-07A091261-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091261-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091261-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091261-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091261-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A091261-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091261-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091261-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091261-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091261-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091261-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091261-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091261-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091261-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091261-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091261-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091261-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091261-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091261-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091261-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A091261-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091261-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091261-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091261-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091261-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091261-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091261-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091261-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091261-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091261-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091261-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091261-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091261-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091261-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091261-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091261-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091261-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-1274a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A091261-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A091261-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A091261-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091261-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091261-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091261-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091261-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091261-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091261-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091261-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091261-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091261-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091261-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091261-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091261-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091261-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091261-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091261-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091261-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091261-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091261-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091261-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091261-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091261-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091261-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091261-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091261-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091261-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091261-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091261-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091261-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091261-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091261-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091261-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091261-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091261-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091261-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091261-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091261-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091261-002AB174a2ff9319b5…

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM500 mg/1

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
60505-3280-5Levetiracetam500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE50020
60505-3280-6Levetiracetam60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE6020
60505-3280-8Levetiracetam1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE100020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3280-6EA - Each60505-32800f9b299b-8ef6-4e5d-88fa-2f4b3c7f2f3b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]7
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]7
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PLEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]7
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]7
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]7
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BLEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]7
WATERINACTIVE INGREDIENT059QF0KO0RLEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]7
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PLEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BLEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RLEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-3280LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]19Current NDC, Legacy NDC, 3 package rows20241012_abc9fada-c5c2-4e07-fb8a-4d1518f7657e.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
Levetiracetam Extended-ReleaseLEVETIRACETAMGolden State Medical Supply, Inc.5dde1889-a217-4493-9a71-9fd39ed046302025-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091261
application number: ANDA091261

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1605362levETIRAcetam 1000 MG 24HR Extended Release Oral TabletPSNabc9fada-c5c2-4e07-fb8a-4d1518f7657e20
807832levETIRAcetam 500 MG 24HR Extended Release Oral TabletPSNabc9fada-c5c2-4e07-fb8a-4d1518f7657e20
846378levETIRAcetam 750 MG 24HR Extended Release Oral TabletPSNabc9fada-c5c2-4e07-fb8a-4d1518f7657e20
160536224 HR levetiracetam 1000 MG Extended Release Oral TabletSCDabc9fada-c5c2-4e07-fb8a-4d1518f7657e20
80783224 HR levetiracetam 500 MG Extended Release Oral TabletSCDabc9fada-c5c2-4e07-fb8a-4d1518f7657e20
84637824 HR levetiracetam 750 MG Extended Release Oral TabletSCDabc9fada-c5c2-4e07-fb8a-4d1518f7657e20
1605362levetiracetam 1000 MG 24 HR Extended Release Oral TabletSYabc9fada-c5c2-4e07-fb8a-4d1518f7657e20
807832levetiracetam 500 MG 24 HR Extended Release Oral TabletSYabc9fada-c5c2-4e07-fb8a-4d1518f7657e20
846378levetiracetam 750 MG 24 HR Extended Release Oral TabletSYabc9fada-c5c2-4e07-fb8a-4d1518f7657e20
807832levETIRAcetam 500 MG 24HR Extended Release Oral TabletPSN5dde1889-a217-4493-9a71-9fd39ed0463013
846378levETIRAcetam 750 MG 24HR Extended Release Oral TabletPSN5dde1889-a217-4493-9a71-9fd39ed0463013
80783224 HR levetiracetam 500 MG Extended Release Oral TabletSCD5dde1889-a217-4493-9a71-9fd39ed0463013
84637824 HR levetiracetam 750 MG Extended Release Oral TabletSCD5dde1889-a217-4493-9a71-9fd39ed0463013
807832levetiracetam 500 MG 24 HR Extended Release Oral TabletSY5dde1889-a217-4493-9a71-9fd39ed0463013
846378levetiracetam 750 MG 24 HR Extended Release Oral TabletSY5dde1889-a217-4493-9a71-9fd39ed0463013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-3280-560505328005500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-3280-5) 2011-09-120000-00-00NoNoCurrent
60505-3280-66050532800660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-3280-6) 2011-09-120000-00-00NoNoCurrent
60505-3280-8605053280081000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-3280-8) 2011-09-120000-00-00NoNoCurrent