Levetiracetam

Product NDC
43063-617
11-digit product format
430630617
Labeler code
43063
Product ID
43063-617_509f6ed1-2ff1-ff40-e063-6394a90af667
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078154
Marketing category
ANDA
Marketing start
2009-01-15
Substance
LEVETIRACETAM
Active strength
500 mg/1
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 · 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…

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
c4b2da6a-ed50-4a54-90bd-32f76b178736Available 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
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-617-60Levetiracetam60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-617-60EA - Each43063-617657ffc5e-2da6-42a6-8bcb-a4a3f20e040612015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
POVIDONEINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-617LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]22Current NDC, Legacy NDC, 1 package rows20240625_c4b2da6a-ed50-4a54-90bd-32f76b178736.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 · 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
ndc (product): 43063-617
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311289levETIRAcetam 500 MG Oral TabletPSNc4b2da6a-ed50-4a54-90bd-32f76b17873624
311289levetiracetam 500 MG Oral TabletSCDc4b2da6a-ed50-4a54-90bd-32f76b17873624

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-617-604306306176060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-617-60) 2015-08-010000-00-00NoNoCurrent