Levetiracetam

Product NDC
68001-116
Requested package NDC
68001-116-07
11-digit product format
680010116
Labeler code
68001
Product ID
68001-116_c4f8afaf-f30f-7a1f-e053-2995a90a05a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA078154
Marketing category
ANDA
Marketing start
2014-02-24
Marketing end
2022-11-30
Substance
LEVETIRACETAM
Active strength
250 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage68001-11668001-116-07DDiscontinued by firm2026-08-11

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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078154-001LEVETIRACETAMLEVETIRACETAM250MGTABLET / ORALAB2009-01-15
A078154-002LEVETIRACETAMLEVETIRACETAM500MGTABLET / ORALAB2009-01-15
A078154-003LEVETIRACETAMLEVETIRACETAM750MGTABLET / ORALAB2009-01-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078154-001AB
A078154-002AB
A078154-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-158072bd15b7f6…

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 UTC2026-02A078154-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078154-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078154-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078154-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078154-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078154-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078154-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078154-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078154-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078154-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078154-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078154-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078154-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078154-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078154-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078154-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078154-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078154-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078154-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078154-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078154-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078154-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078154-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078154-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078154-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078154-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078154-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078154-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078154-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078154-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078154-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078154-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078154-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078154-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078154-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078154-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078154-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078154-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078154-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078154-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-116-03EA - Each68001-116caa10fce-fc52-4179-a232-78b12edee76912014-05-02
68001-116-07EA - Each68001-1168fc9481c-cd15-45ac-8a0b-cc8e4d97433c12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [BLUEPOINT LABORATORIES]5
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [BLUEPOINT LABORATORIES]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVETIRACETAM TABLET, FILM COATED [BLUEPOINT LABORATORIES]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVETIRACETAM TABLET, FILM COATED [BLUEPOINT LABORATORIES]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVETIRACETAM TABLET, FILM COATED [BLUEPOINT LABORATORIES]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLEVETIRACETAM TABLET, FILM COATED [BLUEPOINT LABORATORIES]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVETIRACETAM TABLET, FILM COATED [BLUEPOINT LABORATORIES]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVETIRACETAM TABLET, FILM COATED [BLUEPOINT LABORATORIES]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVETIRACETAM TABLET, FILM COATED [BLUEPOINT LABORATORIES]5
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82LEVETIRACETAM TABLET, FILM COATED [BLUEPOINT LABORATORIES]5
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LEVETIRACETAM TABLET, FILM COATED [BLUEPOINT LABORATORIES]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [BLUEPOINT LABORATORIES]5
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95LEVETIRACETAM TABLET, FILM COATED [BLUEPOINT LABORATORIES]5
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WELEVETIRACETAM TABLET, FILM COATED [BLUEPOINT LABORATORIES]5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LEVETIRACETAM TABLET, FILM COATED [BLUEPOINT LABORATORIES]5
POVIDONESINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [BLUEPOINT LABORATORIES]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [BLUEPOINT LABORATORIES]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVETIRACETAM TABLET, FILM COATED [BLUEPOINT LABORATORIES]5
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVETIRACETAM TABLET, FILM COATED [BLUEPOINT LABORATORIES]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [BLUEPOINT LABORATORIES]5

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.a1b28234-1f7c-40bf-80a7-6cc98b3839fe2026-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078154
application number: ANDA078154
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.1c26c0ad-9d37-45c5-9091-849509f4fc012026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078154
application number: ANDA078154
LevetiracetamLEVETIRACETAMBryant Ranch Prepack90e01877-abcb-4697-a7ed-9afe5ee770502026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078154
application number: ANDA078154
LevetiracetamLEVETIRACETAMPD-Rx Pharmaceuticals, Inc.c4b2da6a-ed50-4a54-90bd-32f76b1787362026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078154
application number: ANDA078154
LevetiracetamLEVETIRACETAMLupin Pharmaceuticals, Inc.df661166-325d-4071-9bc1-f7bf992996d22026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078154
application number: ANDA078154
LevetiracetamLEVETIRACETAMBryant Ranch Prepack24f815ef-58e6-42b9-8137-adcd6c382aa62026-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078154
application number: ANDA078154
LevetiracetamLEVETIRACETAMBryant Ranch Prepack9e3171c9-70e2-4725-8aca-c7f83773940d2026-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078154
application number: ANDA078154
LevetiracetamLEVETIRACETAMPreferred Pharmaceuticals, Inc.e31c6830-4647-4481-b4f1-494a52c48b1b2025-07-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078154
application number: ANDA078154
LevetiracetamLEVETIRACETAMProficient Rx LP6bdbc193-d86b-4bd5-8e88-4ea964d2cdde2024-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078154
application number: ANDA078154

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-116-0768001011607120 TABLET, FILM COATED in 1 BOTTLE (68001-116-07) 2014-02-242022-11-30NoNoCurrent