Levetiracetam

Product NDC
17856-0574
11-digit product format
178560574
Labeler code
17856
Product ID
17856-0574_3624ffe5-0cb0-b7c0-e063-6394a90a69bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
SOLUTION
Route
ORAL
Labeler
Atlantic Biologicals Corp.
Application
ANDA203052
Marketing category
ANDA
Marketing start
2015-06-11
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-0574-11332a3947898…d4bfe170f9cd…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage17856-0574-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage17856-0574-19bebd1f3094a…5416666fcb17…

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
A203052-001LEVETIRACETAMLEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203052-001AA

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 UTC2026-02A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-283f01610625f2…
2019-09-15 20:21 UTC2019-09A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203052-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2013-02-28cb3db0bc1861…

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 UTC2026-02A203052-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203052-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203052-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203052-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203052-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203052-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203052-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203052-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203052-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203052-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203052-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203052-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203052-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203052-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203052-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203052-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203052-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203052-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203052-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203052-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203052-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A203052-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203052-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203052-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203052-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A203052-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203052-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203052-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203052-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203052-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203052-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203052-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203052-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203052-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203052-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203052-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203052-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203052-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203052-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203052-001AA1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Levetiracetam
Brand name suffix
Levetiracetam
Listing expiration
2027-12-31

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
56fed03f-38c3-4273-8fd7-522bc508bf36Available 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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-04-08LEVETIRACETAM ORAL SOLUTION These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
2024-04-08LEVETIRACETAM ORAL SOLUTION These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
2023-01-30LEVETIRACETAM ORAL SOLUTION These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
2023-01-30LEVETIRACETAM ORAL SOLUTION These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
2021-08-25LEVETIRACETAM ORAL SOLUTION These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
2021-08-25LEVETIRACETAM ORAL SOLUTION These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
2020-01-31LEVETIRACETAM ORAL SOLUTION These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
2020-01-31LEVETIRACETAM ORAL SOLUTION These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0574-1LevetiracetamLevetiracetam72 in 1 BOX, UNIT-DOSESOLUTION724
17856-0574-2LevetiracetamLevetiracetam5 mL in 1 CUP, UNIT-DOSESOLUTION54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0574-1ML - Milliliter17856-05741ed00a3a-8998-4cdf-b218-a734586b1d9012020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0574LEVETIRACETAM LEVETIRACETAM (LEVETIRACETAM) SOLUTION [ATLANTIC BIOLOGICALS CORP.]4Current NDC, Legacy NDC, 2 package rows20250529_56fed03f-38c3-4273-8fd7-522bc508bf36.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
Levetiracetam LevetiracetamLEVETIRACETAMAtlantic Biologicals Corp.56fed03f-38c3-4273-8fd7-522bc508bf362026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203052
application number: ANDA203052
ndc (product): 17856-0574
LevetiracetamLEVETIRACETAMAmerican Health Packaging3be7c30b-f35d-4dde-8bf8-24f67bd708652025-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203052
application number: ANDA203052
LevetiracetamLEVETIRACETAM ORALCamber Pharmaceuticals, Inc.0bc8468f-832c-4e71-95a2-db464d4d54bc2024-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203052
application number: ANDA203052
LevetiracetamLEVETIRACETAMNatco Pharma USA LLC34af3602-0188-4d2e-904b-2e40000bb45c2023-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203052
application number: ANDA203052

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN56fed03f-38c3-4273-8fd7-522bc508bf364
403884levetiracetam 100 MG/ML Oral SolutionSCD56fed03f-38c3-4273-8fd7-522bc508bf364
403884levetiracetam 100 MG per 1 ML Oral SolutionSY56fed03f-38c3-4273-8fd7-522bc508bf364
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY56fed03f-38c3-4273-8fd7-522bc508bf364
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY56fed03f-38c3-4273-8fd7-522bc508bf364
403884levetiracetam 500 MG per 5 ML Oral SolutionSY56fed03f-38c3-4273-8fd7-522bc508bf364

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0574-11785605740172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0574-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0574-2) 2021-08-250000-00-00NoNoCurrent
17856-0574-2178560574025 mL in 1 CUP, UNIT-DOSE5 mlHistorical