Levetiracetam

Product NDC
55111-181
Requested package NDC
55111-181-30
11-digit product format
551110181
Labeler code
55111
Product ID
55111-181_2de4ebba-b125-4355-35f5-69b92e56634b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA076920
Marketing category
ANDA
Marketing start
2009-01-15
Substance
LEVETIRACETAM
Active strength
250 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076920-001LEVETIRACETAMLEVETIRACETAM250MGTABLET / ORALAB2009-01-15
A076920-002LEVETIRACETAMLEVETIRACETAM500MGTABLET / ORALAB2009-01-15
A076920-003LEVETIRACETAMLEVETIRACETAM750MGTABLET / ORALAB2009-01-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A076920-001AB
A076920-002AB
A076920-003AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076920-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-1584e616aacf4f…
2026-09-14 22:38:342026-08A076920-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-1584e616aacf4f…
2026-09-14 22:38:342026-08A076920-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-1584e616aacf4f…
2026-08-18 06:07:402026-07A076920-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15caaa826d4ba7…
2026-08-18 06:07:402026-07A076920-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15caaa826d4ba7…
2026-08-18 06:07:402026-07A076920-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076920-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076920-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076920-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076920-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076920-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076920-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A076920-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076920-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076920-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076920-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076920-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076920-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076920-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076920-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076920-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076920-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076920-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076920-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076920-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076920-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076920-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076920-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076920-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076920-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076920-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076920-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076920-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076920-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A076920-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A076920-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076920-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076920-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076920-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076920-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076920-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A076920-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A076920-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A076920-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076920-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076920-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076920-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076920-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076920-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076920-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076920-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076920-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076920-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076920-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076920-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076920-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076920-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076920-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076920-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076920-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076920-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076920-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076920-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076920-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076920-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076920-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076920-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076920-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076920-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076920-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076920-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076920-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076920-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076920-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076920-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076920-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076920-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076920-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076920-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076920-001AB1301d65b070ca…

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
LEVETIRACETAM250 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311288Internal RxNorm lookup
311289Internal RxNorm lookup
311290Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ee03507b-cb35-4fe9-ae7b-85ea89f876f0Available on FDA.report

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
55111-181-01Levetiracetam100 in 1 BOTTLETABLET1007
55111-181-04Levetiracetam120 in 1 BOTTLETABLET1207
55111-181-05Levetiracetam500 in 1 BOTTLETABLET5007
55111-181-30Levetiracetam30 in 1 BOTTLETABLET307
55111-181-79Levetiracetam1 in 1 CARTONTABLET17
55111-181-79Levetiracetam10 in 1 BLISTER PACKTABLET107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-181-04EA - Each55111-181b12a4669-25cb-4ddd-97f1-1e3eaa08c70412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
levetiracetamACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
levetiracetamACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61ULEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
ferric oxide redINACTIVE INGREDIENT1K09F3G675LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTLEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
hypromellose 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
hypromellose 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
magnesium stearateINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQLEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HLEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
povidoneINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
starch, cornINACTIVE INGREDIENTO8232NY3SJLEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
talcINACTIVE INGREDIENT7SEV7J4R1ULEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-181LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]7Current NDC, Legacy NDC, 6 package rows20181207_ee03507b-cb35-4fe9-ae7b-85ea89f876f0.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
LevetiracetamLEVETIRACETAMDr. Reddy's Laboratories Limitedee03507b-cb35-4fe9-ae7b-85ea89f876f02018-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076920
application number: ANDA076920
ndc (package): 55111-181-30
ndc (product): 55111-181
ndc11 (package): 55111018130

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311288levETIRAcetam 250 MG Oral TabletPSNee03507b-cb35-4fe9-ae7b-85ea89f876f07
311289levETIRAcetam 500 MG Oral TabletPSNee03507b-cb35-4fe9-ae7b-85ea89f876f07
311290levETIRAcetam 750 MG Oral TabletPSNee03507b-cb35-4fe9-ae7b-85ea89f876f07
311288levetiracetam 250 MG Oral TabletSCDee03507b-cb35-4fe9-ae7b-85ea89f876f07
311289levetiracetam 500 MG Oral TabletSCDee03507b-cb35-4fe9-ae7b-85ea89f876f07
311290levetiracetam 750 MG Oral TabletSCDee03507b-cb35-4fe9-ae7b-85ea89f876f07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-181-305511101813030 TABLET in 1 BOTTLE (55111-181-30) 30 tablet2009-01-150000-00-00NoNoCurrent