Levetiracetam

Product NDC
44567-500
Requested package NDC
44567-500-10
11-digit product format
445670500
Labeler code
44567
Product ID
44567-500_8f6562af-1782-456f-a372-d6c6fef11e0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
NDA202543
Marketing category
NDA
Marketing start
2020-08-24
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
5 mg/mL
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage44567-50044567-500-10DDiscontinued by firm2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N202543-001LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAM500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-09
N202543-002LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAM1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-09
N202543-003LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAM1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-09
N202543-004LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAM250MG/50ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAVENOUSRLD2020-12-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N202543-001AP
N202543-002AP
N202543-003AP

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 · 158 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N202543-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202543-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202543-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202543-004LEVETIRACETAM IN SODIUM CHLORIDE250MG/50ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAVENOUSRLD2020-12-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202543-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202543-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202543-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202543-004LEVETIRACETAM IN SODIUM CHLORIDE250MG/50ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAVENOUSRLD2020-12-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N202543-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202543-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202543-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202543-004LEVETIRACETAM IN SODIUM CHLORIDE250MG/50ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAVENOUSRLD2020-12-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202543-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202543-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202543-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202543-004LEVETIRACETAM IN SODIUM CHLORIDE250MG/50ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAVENOUSRLD2020-12-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202543-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202543-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202543-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202543-004LEVETIRACETAM IN SODIUM CHLORIDE250MG/50ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAVENOUSRLD2020-12-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202543-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202543-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202543-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202543-004LEVETIRACETAM IN SODIUM CHLORIDE250MG/50ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAVENOUSRLD2020-12-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202543-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202543-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202543-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202543-004LEVETIRACETAM IN SODIUM CHLORIDE250MG/50ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAVENOUSRLD2020-12-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202543-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202543-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202543-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202543-004LEVETIRACETAM IN SODIUM CHLORIDE250MG/50ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAVENOUSRLD2020-12-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202543-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202543-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202543-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202543-004LEVETIRACETAM IN SODIUM CHLORIDE250MG/50ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAVENOUSRLD2020-12-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202543-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N202543-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N202543-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2011-11-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N202543-004LEVETIRACETAM IN SODIUM CHLORIDE250MG/50ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAVENOUSRLD2020-12-14d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N202543-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202543-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202543-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202543-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202543-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202543-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N202543-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202543-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202543-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202543-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202543-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202543-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202543-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202543-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202543-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202543-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202543-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202543-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202543-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202543-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202543-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202543-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202543-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202543-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202543-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202543-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202543-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202543-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N202543-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N202543-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202543-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202543-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202543-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202543-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202543-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202543-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202543-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202543-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202543-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N202543-001AP18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-500-01ML - Milliliter44567-500304e7417-27a0-4f18-ba7e-b3170781f1d412022-07-06
44567-500-10ML - Milliliter44567-5009b5c4ea4-6f4e-4002-a8ee-622d8e58bac012022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-500LEVETIRACETAM INJECTION [WG CRITICAL CARE, LLC]5Legacy NDC20240601_62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevetiracetamLEVETIRACETAMWG Critical Care, LLC62f3d1c8-ca5b-4760-9fc9-41e4fb4cc9262024-03-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 202543
application number: NDA202543
LevetiracetamLEVETIRACETAMMylan Institutional LLC70e52e89-3844-4cd9-a406-b29e9520a12c2024-03-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 202543
application number: NDA202543
LevetiracetamLEVETIRACETAMWG Critical Care, LLC5e5b0ed3-b104-45a7-bb3e-ee56febb46e82023-10-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 202543
application number: NDA202543

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-500-104456705001010 BAG in 1 CARTON (44567-500-10) > 50 mL in 1 BAG (44567-500-01) 10 bag2020-08-240000-00-00NoNoCurrent