Levetiracetam

Product NDC
68180-117
11-digit product format
681800117
Labeler code
68180
Product ID
68180-117_8690e365-04d0-44ee-98ec-281e438ee0b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA091399
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A091399-001LEVETIRACETAMLEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12
A091399-002LEVETIRACETAMLEVETIRACETAM750MGTABLET, 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
A091399-001AB
A091399-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091399-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12caaa826d4ba7…
2026-08-18 06:07:402026-07A091399-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091399-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091399-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091399-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091399-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A091399-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091399-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091399-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091399-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091399-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091399-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091399-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091399-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091399-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091399-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091399-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091399-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091399-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091399-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091399-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A091399-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091399-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091399-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091399-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091399-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091399-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091399-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091399-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091399-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091399-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091399-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091399-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091399-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091399-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091399-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091399-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091399-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091399-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091399-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2011-09-12bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A091399-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091399-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091399-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091399-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091399-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091399-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091399-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091399-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091399-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091399-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091399-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091399-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091399-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091399-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091399-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091399-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091399-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091399-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091399-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091399-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091399-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091399-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091399-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091399-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091399-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091399-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091399-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091399-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091399-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091399-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091399-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091399-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091399-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091399-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091399-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091399-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091399-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091399-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091399-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091399-002AB1bb7c543d1eb4…

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
807832Internal RxNorm lookup
846378Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
18648f51-a37c-41e1-b451-123bc0cf5446Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
68180-117-02Levetiracetam500 in 1 BOTTLETABLET, EXTENDED RELEASE50022
68180-117-07Levetiracetam60 in 1 BOTTLETABLET, EXTENDED RELEASE6022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-117-07EA - Each68180-11799e62430-ad27-4b5a-8405-a028a0c98f9f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JLEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EALEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4LEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
SHELLACINACTIVE INGREDIENT46N107B71OLEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-117LEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]21Current NDC, Legacy NDC, 2 package rows20250201_18648f51-a37c-41e1-b451-123bc0cf5446.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevetiracetamLEVETIRACETAMBluePoint Laboratories402b488c-1733-4bf7-a7a8-b60805b022c92026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091399
application number: ANDA091399
LevetiracetamLEVETIRACETAMLupin Pharmaceuticals, Inc.18648f51-a37c-41e1-b451-123bc0cf54462025-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091399
application number: ANDA091399
ndc (product): 68180-117

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
807832levETIRAcetam 500 MG 24HR Extended Release Oral TabletPSN18648f51-a37c-41e1-b451-123bc0cf544622
846378levETIRAcetam 750 MG 24HR Extended Release Oral TabletPSN18648f51-a37c-41e1-b451-123bc0cf544622
80783224 HR levetiracetam 500 MG Extended Release Oral TabletSCD18648f51-a37c-41e1-b451-123bc0cf544622
84637824 HR levetiracetam 750 MG Extended Release Oral TabletSCD18648f51-a37c-41e1-b451-123bc0cf544622
807832levetiracetam 500 MG 24 HR Extended Release Oral TabletSY18648f51-a37c-41e1-b451-123bc0cf544622
846378levetiracetam 750 MG 24 HR Extended Release Oral TabletSY18648f51-a37c-41e1-b451-123bc0cf544622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-117-0268180011702500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-117-02) 2011-09-120000-00-00NoNoCurrent
68180-117-076818001170760 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-117-07) 2011-09-120000-00-00NoNoCurrent