LEVETIRACETAM

Product NDC
43547-346
11-digit product format
435470346
Labeler code
43547
Product ID
43547-346_801f853c-1f42-4d65-ae2d-2bace0d5f3f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Solco healthcare U.S., LLC
Application
ANDA203468
Marketing category
ANDA
Marketing start
2014-05-01
Substance
LEVETIRACETAM
Active strength
750 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203468-001LEVETIRACETAMLEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2015-05-21
A203468-002LEVETIRACETAMLEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2015-05-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A203468-001AB
A203468-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203468-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2015-05-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203468-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2015-05-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203468-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2015-05-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203468-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2015-05-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203468-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2015-05-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203468-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2015-05-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203468-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2015-05-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203468-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2015-05-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203468-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2015-05-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203468-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2015-05-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203468-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2015-05-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203468-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2015-05-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203468-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2015-05-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203468-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2015-05-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203468-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2015-05-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203468-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2015-05-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203468-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2015-05-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203468-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2015-05-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203468-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2015-05-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A203468-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2015-05-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203468-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2015-05-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203468-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2015-05-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203468-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2015-05-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203468-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2015-05-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203468-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2015-05-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203468-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2015-05-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203468-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2015-05-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203468-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2015-05-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203468-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2015-05-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203468-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2015-05-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203468-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2015-05-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203468-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2015-05-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203468-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2015-05-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203468-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2015-05-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203468-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2015-05-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203468-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2015-05-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203468-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2015-05-21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203468-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2015-05-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203468-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2015-05-21782e0a99824c…
2021-12-28 21:50 UTC2021-12A203468-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2015-05-21782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203468-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203468-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203468-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203468-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203468-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203468-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203468-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203468-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203468-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203468-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203468-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203468-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203468-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203468-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203468-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203468-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203468-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203468-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203468-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203468-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203468-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203468-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203468-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203468-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203468-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203468-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203468-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203468-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203468-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203468-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203468-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203468-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203468-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203468-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203468-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203468-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203468-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203468-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203468-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203468-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
LEVETIRACETAM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM750 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
807832Internal RxNorm lookup
846378Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bc8644ed-3320-47b5-adf3-8b972bea8abdAvailable on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-346-06LEVETIRACETAM60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE6014
43547-346-50LEVETIRACETAM500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE50014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-346-06EA - Each43547-3462a00a335-a76c-4205-b427-252e5db21c3312015-10-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-346LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [SOLCO HEALTHCARE U.S., LLC]13Current NDC, Legacy NDC, 2 package rows20240617_bc8644ed-3320-47b5-adf3-8b972bea8abd.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEVETIRACETAMLEVETIRACETAMBryant Ranch Prepackace53552-d616-45e8-9f99-2f0041d0b4302026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203468
application number: ANDA203468
LEVETIRACETAMLEVETIRACETAMREMEDYREPACK INC.9bdef24b-c50e-4e6a-8650-59d78009f4722026-03-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203468
application number: ANDA203468
Levetiracetam ERLEVETIRACETAM ERDirect_Rx03c449a1-9b40-a7da-e063-6394a90a984e2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203468
application number: ANDA203468
LEVETIRACETAMLEVETIRACETAMSolco healthcare U.S., LLCbc8644ed-3320-47b5-adf3-8b972bea8abd2024-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203468
application number: ANDA203468
ndc (product): 43547-346

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
807832levETIRAcetam 500 MG 24HR Extended Release Oral TabletPSNbc8644ed-3320-47b5-adf3-8b972bea8abd14
846378levETIRAcetam 750 MG 24HR Extended Release Oral TabletPSNbc8644ed-3320-47b5-adf3-8b972bea8abd14
80783224 HR levetiracetam 500 MG Extended Release Oral TabletSCDbc8644ed-3320-47b5-adf3-8b972bea8abd14
84637824 HR levetiracetam 750 MG Extended Release Oral TabletSCDbc8644ed-3320-47b5-adf3-8b972bea8abd14
807832levetiracetam 500 MG 24 HR Extended Release Oral TabletSYbc8644ed-3320-47b5-adf3-8b972bea8abd14
846378levetiracetam 750 MG 24 HR Extended Release Oral TabletSYbc8644ed-3320-47b5-adf3-8b972bea8abd14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-346-064354703460660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-346-06) 2014-05-010000-00-00NoNoCurrent
43547-346-5043547034650500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-346-50) 2014-05-010000-00-00NoNoCurrent