FDA.reportPublic FDA data

LEVETIRACETAM solution

Product NDC
62135-548
11-digit product format
621350548
Labeler code
62135
Product ID
62135-548_4ce97296-8459-d216-e063-6394a90a1f42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA090263
Marketing category
ANDA
Marketing start
2009-04-03
Substance
LEVETIRACETAM
Active strength
100 mg/mL
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A090263-001LEVETIRACETAMLEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090263-001AA

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 UTC2026-02A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-033f01610625f2…
2019-09-15 20:21 UTC2019-09A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090263-001LEVETIRACETAM100MG/MLSOLUTION / ORALAA2009-04-03cb3db0bc1861…

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 UTC2026-02A090263-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090263-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090263-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090263-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090263-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090263-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090263-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090263-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090263-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090263-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090263-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090263-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090263-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090263-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090263-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090263-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090263-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090263-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090263-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090263-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090263-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A090263-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090263-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090263-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090263-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A090263-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090263-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090263-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090263-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090263-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090263-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090263-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090263-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090263-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090263-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090263-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090263-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090263-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090263-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090263-001AA1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
LEVETIRACETAM solution
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
61eb57a9-5df2-4426-9f0c-a75e2f356b11Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-548-47LEVETIRACETAM solution473 mL in 1 BOTTLESOLUTION4735

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-548-24ML - Milliliter62135-5486953cfef-2ff3-4a67-9f0f-0144508be43e12024-09-09
62135-548-45ML - Milliliter62135-5487c112a3c-8b29-4219-9248-8ed14e7bd8c912024-09-09
62135-548-47ML - Milliliter62135-5481a72462d-09b0-4263-bb6d-3b2b9f10181712022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-548LEVETIRACETAM SOLUTION (LEVETIRACETAM) SOLUTION [CHARTWELL RX, LLC]3Current NDC, Legacy NDC, 1 package rows20240601_61eb57a9-5df2-4426-9f0c-a75e2f356b11.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
LEVETIRACETAM solutionLEVETIRACETAMChartwell RX, LLC61eb57a9-5df2-4426-9f0c-a75e2f356b112026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090263
application number: ANDA090263
ndc (product): 62135-548
LEVETIRACETAM solutionLEVETIRACETAMChartwell Governmental & Specialty RX, LLC.e1ebd960-79a4-4632-b727-4e98118241132025-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090263
application number: ANDA090263

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN61eb57a9-5df2-4426-9f0c-a75e2f356b115
403884levetiracetam 100 MG/ML Oral SolutionSCD61eb57a9-5df2-4426-9f0c-a75e2f356b115
403884levetiracetam 100 MG per 1 ML Oral SolutionSY61eb57a9-5df2-4426-9f0c-a75e2f356b115
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY61eb57a9-5df2-4426-9f0c-a75e2f356b115
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY61eb57a9-5df2-4426-9f0c-a75e2f356b115
403884levetiracetam 500 MG per 5 ML Oral SolutionSY61eb57a9-5df2-4426-9f0c-a75e2f356b115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-548-4762135054847473 mL in 1 BOTTLE (62135-548-47) 473 ml2022-06-080000-00-00NoNoCurrent