FDA.reportPublic FDA data

Levetiracetam

Product NDC
67046-0420
Requested package NDC
67046-0420-3
11-digit product format
670460420
Labeler code
67046
Product ID
67046-0420_53844dda-7bb6-e504-e063-6294a90a601d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Coupler LLC
Application
ANDA078993
Marketing category
ANDA
Marketing start
2026-06-05
Substance
LEVETIRACETAM
Active strength
500 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078993-001LEVETIRACETAMLEVETIRACETAM250MGTABLET / ORALAB2009-01-15
A078993-002LEVETIRACETAMLEVETIRACETAM500MGTABLET / ORALAB2009-01-15
A078993-003LEVETIRACETAMLEVETIRACETAM750MGTABLET / ORALAB2009-01-15
A078993-004LEVETIRACETAMLEVETIRACETAM1GMTABLET / ORALAB2009-01-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A078993-001AB
A078993-002AB
A078993-003AB
A078993-004AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A078993-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15a50c72e98297…
2026-08-01 22:54:322026-06A078993-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15a50c72e98297…
2026-08-01 22:54:322026-06A078993-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15a50c72e98297…
2026-08-01 22:54:322026-06A078993-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078993-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078993-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078993-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A078993-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevetiracetamLEVETIRACETAMUnit Dose Solutions, Inc.551626eb-3282-e439-e063-6294a90a83142026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMCoupler LLC53843871-23e3-974e-e063-6394a90a80422026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
ndc (package): 67046-0420-3
ndc (product): 67046-0420
ndc11 (package): 67046042003
LevetiracetamLEVETIRACETAMCoupler LLC51b66893-f7d6-8f9d-e063-6294a90a8e9b2026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMCoupler LLC5037a86a-21f2-d793-e063-6394a90a2cb52026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMA-S Medication Solutions6e31e766-6504-4f20-8831-1953363cace02025-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMA-S Medication Solutions01aef7f7-6092-4e39-8451-dc02d8db92542025-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMA-S Medication Solutions58ed7049-44c6-4f97-9174-c0e1504586a62025-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMA-S Medication Solutions5eb7bea5-c95f-4a38-a5bb-c20d1549c7972025-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMA-S Medication Solutionsbc12f0b0-e05c-48e4-ad08-0ff14a818a642025-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMMajor Pharmaceuticalsc4b27429-50a3-467c-a5ff-7e49a01a10882025-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMCardinal Health 107, LLC0348fec4-d919-4307-ac90-35360819bc002025-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMBluePoint Laboratories8b74b8bc-d95c-4471-8f74-c3117243bf892024-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMAmerican Health Packagingfc8bf57e-8aa2-4d3c-856d-b19de65e3ba02024-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMAmerican Health Packaging031a32e1-675a-4efe-a66b-40beb4fe51012024-06-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993
LevetiracetamLEVETIRACETAMAurobindo Pharma Limited2471ee03-d747-4113-86d0-1aa93c8f3eba2024-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078993
application number: ANDA078993

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM500 mg/1

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
311289Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
53843871-23e3-974e-e063-6394a90a8042Available on FDA.report

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleStatus
67046-0420-36704604200330 TABLET, FILM COATED in 1 BLISTER PACK (67046-0420-3)2026-06-050Current