Levetiracetam

Product NDC
65862-250
11-digit product format
658620250
Labeler code
65862
Product ID
65862-250_8cd74ce7-ea18-456e-bc82-34b643055e56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
SOLUTION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA079063
Marketing category
ANDA
Marketing start
2009-01-15
Substance
LEVETIRACETAM
Active strength
100 mg/mL
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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079063-001LEVETIRACETAMLEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A079063-001AA

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-153f01610625f2…
2019-09-15 20:21 UTC2019-09A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079063-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-01-15cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A079063-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079063-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079063-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079063-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079063-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079063-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079063-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079063-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079063-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079063-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079063-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079063-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079063-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079063-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079063-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079063-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079063-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079063-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079063-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079063-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079063-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A079063-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079063-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079063-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079063-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A079063-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A079063-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079063-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079063-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079063-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079063-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079063-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079063-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079063-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A079063-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A079063-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079063-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079063-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079063-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079063-001AA1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Levetiracetam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM100 mg/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
403884Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f65ec19d-b90e-452e-b761-c68b1cf2c892Available 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
65862-250-05Levetiracetam500 mL in 1 BOTTLE, PLASTICSOLUTION50026
65862-250-47Levetiracetam473 mL in 1 BOTTLE, PLASTICSOLUTION47326

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-250-47ML - Milliliter65862-250e1061a17-c5ee-4eda-bca7-ef0831df069d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9LEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPLEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
GLYCYRRHIZIN, AMMONIATEDINACTIVE INGREDIENT3VRD35U26CLEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
MALTITOLINACTIVE INGREDIENTD65DG142WKLEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KLEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
WATERINACTIVE INGREDIENT059QF0KO0RLEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-250LEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]26Current NDC, Legacy NDC, 2 package rows20240918_f65ec19d-b90e-452e-b761-c68b1cf2c892.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.94d042f7-93b9-43bd-9ace-cfc61903b4d72026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079063
application number: ANDA079063
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.74ccc9f1-b957-4b1b-9464-1b5e3318c9162026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079063
application number: ANDA079063
LevetiracetamLEVETIRACETAMNorthStar Rx LLC483a42b9-c8f3-4f8b-98be-fcac5ab23c7c2024-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079063
application number: ANDA079063
LevetiracetamLEVETIRACETAMAurobindo Pharma Limitedf65ec19d-b90e-452e-b761-c68b1cf2c8922024-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079063
application number: ANDA079063
ndc (product): 65862-250

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSNf65ec19d-b90e-452e-b761-c68b1cf2c89226
403884levetiracetam 100 MG/ML Oral SolutionSCDf65ec19d-b90e-452e-b761-c68b1cf2c89226
403884levetiracetam 100 MG per 1 ML Oral SolutionSYf65ec19d-b90e-452e-b761-c68b1cf2c89226
403884levetiracetam 1000 MG per 10 ML Oral SolutionSYf65ec19d-b90e-452e-b761-c68b1cf2c89226
403884levetiracetam 1500 MG per 15 ML Oral SolutionSYf65ec19d-b90e-452e-b761-c68b1cf2c89226
403884levetiracetam 500 MG per 5 ML Oral SolutionSYf65ec19d-b90e-452e-b761-c68b1cf2c89226
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN94d042f7-93b9-43bd-9ace-cfc61903b4d79
403884levetiracetam 100 MG/ML Oral SolutionSCD94d042f7-93b9-43bd-9ace-cfc61903b4d79
403884levetiracetam 100 MG per 1 ML Oral SolutionSY94d042f7-93b9-43bd-9ace-cfc61903b4d79
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY94d042f7-93b9-43bd-9ace-cfc61903b4d79
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY94d042f7-93b9-43bd-9ace-cfc61903b4d79
403884levetiracetam 500 MG per 5 ML Oral SolutionSY94d042f7-93b9-43bd-9ace-cfc61903b4d79
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN74ccc9f1-b957-4b1b-9464-1b5e3318c9166
403884levetiracetam 100 MG/ML Oral SolutionSCD74ccc9f1-b957-4b1b-9464-1b5e3318c9166
403884levetiracetam 100 MG per 1 ML Oral SolutionSY74ccc9f1-b957-4b1b-9464-1b5e3318c9166
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY74ccc9f1-b957-4b1b-9464-1b5e3318c9166
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY74ccc9f1-b957-4b1b-9464-1b5e3318c9166
403884levetiracetam 500 MG per 5 ML Oral SolutionSY74ccc9f1-b957-4b1b-9464-1b5e3318c9166

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-250-0565862025005500 mL in 1 BOTTLE, PLASTIC (65862-250-05) 500 ml2009-01-150000-00-00NoNoCurrent
65862-250-4765862025047473 mL in 1 BOTTLE, PLASTIC (65862-250-47) 473 ml2009-01-150000-00-00NoNoCurrent