Levetiracetam

Product NDC
60505-3517
11-digit product format
605053517
Labeler code
60505
Product ID
60505-3517_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
750 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 44.

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A091261-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12c2088c7a36db…
2026-10-15 13:18:302026-09A091261-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12c2088c7a36db…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A091261-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A091261-002AB1c2088c7a36db…
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…

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
LEVETIRACETAM750 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
60505-3517-5Levetiracetam500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE50020
60505-3517-6Levetiracetam60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE6020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3517-6EA - Each60505-35172a024a2d-ea7f-4625-ba09-b127b6169b7212012-07-24

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
60505-3517LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]19Current NDC, Legacy NDC, 2 package rows20241012_abc9fada-c5c2-4e07-fb8a-4d1518f7657e.zip

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
60505-3517-560505351705500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-3517-5) 2011-09-120000-00-00NoNoCurrent
60505-3517-66050535170660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-3517-6) 2011-09-120000-00-00NoNoCurrent