Levetiracetam

Product NDC
71930-065
Requested package NDC
71930-065-60
11-digit product format
719300065
Labeler code
71930
Product ID
71930-065_bc9d8d29-4a90-6efc-e053-2a95a90a0ff2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET
Route
ORAL
Labeler
EYWA Pharma Inc.
Application
ANDA090767
Marketing category
ANDA
Marketing start
2019-12-05
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
1000 mg/1
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 packagepackage71930-06571930-065-60DDiscontinued by firm2026-08-10

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
A090767-001LEVETIRACETAMLEVETIRACETAM250MGTABLET / ORALAB2010-07-28
A090767-002LEVETIRACETAMLEVETIRACETAM500MGTABLET / ORALAB2010-07-28
A090767-003LEVETIRACETAMLEVETIRACETAM750MGTABLET / ORALAB2010-07-28
A090767-004LEVETIRACETAMLEVETIRACETAM1GMTABLET / ORALAB2010-07-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090767-001AB
A090767-002AB
A090767-003AB
A090767-004AB

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.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090767-001LEVETIRACETAM250MGTABLET / ORALAB2010-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090767-002LEVETIRACETAM500MGTABLET / ORALAB2010-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090767-003LEVETIRACETAM750MGTABLET / ORALAB2010-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090767-004LEVETIRACETAM1GMTABLET / ORALAB2010-07-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090767-001LEVETIRACETAM250MGTABLET / ORALAB2010-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090767-002LEVETIRACETAM500MGTABLET / ORALAB2010-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090767-003LEVETIRACETAM750MGTABLET / ORALAB2010-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090767-004LEVETIRACETAM1GMTABLET / ORALAB2010-07-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A090767-001LEVETIRACETAM250MGTABLET / ORALAB2010-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090767-002LEVETIRACETAM500MGTABLET / ORALAB2010-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090767-003LEVETIRACETAM750MGTABLET / ORALAB2010-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090767-004LEVETIRACETAM1GMTABLET / ORALAB2010-07-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090767-001LEVETIRACETAM250MGTABLET / ORALAB2010-07-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090767-002LEVETIRACETAM500MGTABLET / ORALAB2010-07-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090767-003LEVETIRACETAM750MGTABLET / ORALAB2010-07-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090767-004LEVETIRACETAM1GMTABLET / ORALAB2010-07-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090767-001LEVETIRACETAM250MGTABLET / ORALAB2010-07-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090767-002LEVETIRACETAM500MGTABLET / ORALAB2010-07-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090767-003LEVETIRACETAM750MGTABLET / ORALAB2010-07-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090767-004LEVETIRACETAM1GMTABLET / ORALAB2010-07-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090767-001LEVETIRACETAM250MGTABLET / ORALAB2010-07-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090767-002LEVETIRACETAM500MGTABLET / ORALAB2010-07-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090767-003LEVETIRACETAM750MGTABLET / ORALAB2010-07-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090767-004LEVETIRACETAM1GMTABLET / ORALAB2010-07-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090767-001LEVETIRACETAM250MGTABLET / ORALAB2010-07-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090767-002LEVETIRACETAM500MGTABLET / ORALAB2010-07-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090767-003LEVETIRACETAM750MGTABLET / ORALAB2010-07-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090767-004LEVETIRACETAM1GMTABLET / ORALAB2010-07-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090767-001LEVETIRACETAM250MGTABLET / ORALAB2010-07-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090767-002LEVETIRACETAM500MGTABLET / ORALAB2010-07-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090767-003LEVETIRACETAM750MGTABLET / ORALAB2010-07-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090767-004LEVETIRACETAM1GMTABLET / ORALAB2010-07-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090767-001LEVETIRACETAM250MGTABLET / ORALAB2010-07-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090767-002LEVETIRACETAM500MGTABLET / ORALAB2010-07-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090767-003LEVETIRACETAM750MGTABLET / ORALAB2010-07-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090767-004LEVETIRACETAM1GMTABLET / ORALAB2010-07-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090767-001LEVETIRACETAM250MGTABLET / ORALAB2010-07-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A090767-002LEVETIRACETAM500MGTABLET / ORALAB2010-07-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A090767-003LEVETIRACETAM750MGTABLET / ORALAB2010-07-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A090767-004LEVETIRACETAM1GMTABLET / ORALAB2010-07-28d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090767-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090767-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090767-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090767-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090767-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090767-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090767-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090767-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090767-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090767-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090767-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090767-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090767-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090767-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090767-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090767-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090767-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090767-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090767-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090767-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090767-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090767-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090767-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090767-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090767-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090767-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090767-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090767-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090767-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090767-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090767-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090767-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090767-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090767-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090767-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090767-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090767-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090767-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090767-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090767-004AB1d06236e962d9…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71930-065-60EA - Each71930-065685c4cce-674e-4f38-8e23-d0d3149ded1012019-12-10

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
LevetiracetamLEVETIRACETAMA-S Medication Solutions671a1ae1-f672-48da-8a69-94c1474720032025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090767
application number: ANDA090767
LevetiracetamLEVETIRACETAMRising Pharma Holdings, Inc.db423b93-d7c2-4cf2-829b-24b657f27f932025-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090767
application number: ANDA090767
LevetiracetamLEVETIRACETAMAmneal Pharmaceuticals LLCd7932a2c-a3b7-46df-a306-1f17716160a02017-11-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090767
application number: ANDA090767

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSN2d2af1f9-51a5-4ba4-89a2-451e8ed049f71
387003levetiracetam 1000 MG Oral TabletSCD2d2af1f9-51a5-4ba4-89a2-451e8ed049f71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71930-065-607193000656060 TABLET in 1 BOTTLE (71930-065-60) 60 tablet2019-12-050000-00-00NoNoCurrent