LEVETIRACETAM TABLETS

Manufacturer
Zydus Lifesciences Limited
Effective date
2024-11-30
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 20:47:58

Label at a glance#

Productlevetiracetam
Active ingredientLEVETIRACETAM
Label structure2 sections

Label contents#

Full prescribing information#

SPL MEDGUIDE SECTION

Manufactured by:

Cadila Healthcare Ltd.

India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-703-19 in bottle of 120 tablets

Levetiracetam Tablets, 250 mg

Rx only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-704-10

Levetiracetam Tablets, 1000 mg

1000 tablets

Rx only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65841-70365841-703-19, 65841-703-10, 65841-703-77
65841-70465841-704-14, 65841-704-10, 65841-704-77

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
A078918-001LEVETIRACETAMLEVETIRACETAM250MGTABLET / ORALAB2009-04-29
A078918-002LEVETIRACETAMLEVETIRACETAM1GMTABLET / ORALAB2009-04-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078918-001AB
A078918-002AB

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 22:38:342026-08A078918-001LEVETIRACETAM250MGTABLET / ORALAB2009-04-2984e616aacf4f…
2026-09-14 22:38:342026-08A078918-002LEVETIRACETAM1GMTABLET / ORALAB2009-04-2984e616aacf4f…
2026-08-18 06:07:402026-07A078918-001LEVETIRACETAM250MGTABLET / ORALAB2009-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07A078918-002LEVETIRACETAM1GMTABLET / ORALAB2009-04-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078918-001LEVETIRACETAM250MGTABLET / ORALAB2009-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078918-002LEVETIRACETAM1GMTABLET / ORALAB2009-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078918-001LEVETIRACETAM250MGTABLET / ORALAB2009-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078918-002LEVETIRACETAM1GMTABLET / ORALAB2009-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078918-001LEVETIRACETAM250MGTABLET / ORALAB2009-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078918-002LEVETIRACETAM1GMTABLET / ORALAB2009-04-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078918-001LEVETIRACETAM250MGTABLET / ORALAB2009-04-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078918-002LEVETIRACETAM1GMTABLET / ORALAB2009-04-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078918-001LEVETIRACETAM250MGTABLET / ORALAB2009-04-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078918-002LEVETIRACETAM1GMTABLET / ORALAB2009-04-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078918-001LEVETIRACETAM250MGTABLET / ORALAB2009-04-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078918-002LEVETIRACETAM1GMTABLET / ORALAB2009-04-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078918-001LEVETIRACETAM250MGTABLET / ORALAB2009-04-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078918-002LEVETIRACETAM1GMTABLET / ORALAB2009-04-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078918-001LEVETIRACETAM250MGTABLET / ORALAB2009-04-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078918-002LEVETIRACETAM1GMTABLET / ORALAB2009-04-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078918-001LEVETIRACETAM250MGTABLET / ORALAB2009-04-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078918-002LEVETIRACETAM1GMTABLET / ORALAB2009-04-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078918-001LEVETIRACETAM250MGTABLET / ORALAB2009-04-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A078918-002LEVETIRACETAM1GMTABLET / ORALAB2009-04-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078918-001LEVETIRACETAM250MGTABLET / ORALAB2009-04-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078918-002LEVETIRACETAM1GMTABLET / ORALAB2009-04-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078918-001LEVETIRACETAM250MGTABLET / ORALAB2009-04-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078918-002LEVETIRACETAM1GMTABLET / ORALAB2009-04-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078918-001LEVETIRACETAM250MGTABLET / ORALAB2009-04-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078918-002LEVETIRACETAM1GMTABLET / ORALAB2009-04-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078918-001LEVETIRACETAM250MGTABLET / ORALAB2009-04-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078918-002LEVETIRACETAM1GMTABLET / ORALAB2009-04-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078918-001LEVETIRACETAM250MGTABLET / ORALAB2009-04-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078918-002LEVETIRACETAM1GMTABLET / ORALAB2009-04-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078918-001LEVETIRACETAM250MGTABLET / ORALAB2009-04-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078918-002LEVETIRACETAM1GMTABLET / ORALAB2009-04-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078918-001LEVETIRACETAM250MGTABLET / ORALAB2009-04-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078918-002LEVETIRACETAM1GMTABLET / ORALAB2009-04-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078918-001LEVETIRACETAM250MGTABLET / ORALAB2009-04-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078918-002LEVETIRACETAM1GMTABLET / ORALAB2009-04-2974a2ff9319b5…

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 22:38:342026-08A078918-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078918-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A078918-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078918-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078918-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078918-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078918-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078918-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078918-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078918-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078918-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078918-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078918-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078918-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078918-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078918-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078918-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078918-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078918-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078918-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078918-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078918-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078918-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078918-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078918-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078918-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078918-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078918-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078918-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078918-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078918-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078918-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078918-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078918-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078918-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078918-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078918-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078918-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078918-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078918-002AB174a2ff9319b5…

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
047b40b2-6f8f-4e2c-a965-7658b228414ad696e0d3-3d3d-4669-9fd7-4c96db490e572025-04-26Exact identifier
spl set id: d696e0d3-3d3d-4669-9fd7-4c96db490e57

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.