Levetiracetam

Product NDC
71205-881
11-digit product format
712050881
Labeler code
71205
Product ID
71205-881_cb0d9a15-fb02-4393-bdf7-a88dc4b42d6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA205130
Marketing category
ANDA
Marketing start
2021-09-30
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 42.

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
A205130-001LEVETIRACETAMLEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2020-11-27
A205130-002LEVETIRACETAMLEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2020-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205130-001AB
A205130-002AB

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 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A205130-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2020-11-27caaa826d4ba7…
2026-08-18 06:07:402026-07A205130-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2020-11-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205130-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2020-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205130-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2020-11-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205130-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2020-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205130-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2020-11-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A205130-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2020-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205130-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2020-11-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205130-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2020-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205130-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2020-11-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205130-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2020-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205130-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2020-11-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205130-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2020-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205130-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2020-11-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205130-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2020-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205130-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2020-11-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205130-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2020-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205130-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2020-11-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205130-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2020-11-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205130-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2020-11-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205130-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2020-11-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A205130-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2020-11-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205130-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2020-11-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205130-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2020-11-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205130-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2020-11-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205130-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2020-11-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205130-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2020-11-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205130-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2020-11-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205130-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2020-11-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205130-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2020-11-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205130-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2020-11-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205130-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2020-11-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205130-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2020-11-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205130-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2020-11-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205130-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2020-11-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205130-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2020-11-274b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A205130-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2020-11-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205130-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2020-11-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205130-001LEVETIRACETAM500MGTABLET, EXTENDED RELEASE / ORALAB2020-11-27782e0a99824c…
2021-12-28 21:50 UTC2021-12A205130-002LEVETIRACETAM750MGTABLET, EXTENDED RELEASE / ORALAB2020-11-27782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A205130-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205130-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205130-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205130-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205130-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205130-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205130-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205130-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205130-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205130-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205130-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205130-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205130-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205130-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205130-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205130-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205130-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205130-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205130-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205130-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205130-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205130-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205130-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205130-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205130-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205130-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205130-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205130-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205130-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205130-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205130-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205130-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205130-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205130-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205130-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205130-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A205130-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205130-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205130-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A205130-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Levetiracetam
Brand name suffix
ER
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
57b9dccb-6ee6-4e89-ab26-4c478e2df2b5Available 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
71205-881-00LevetiracetamER100 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1002
71205-881-11LevetiracetamER1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE10002
71205-881-30LevetiracetamER30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE302
71205-881-55LevetiracetamER500 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE5002
71205-881-60LevetiracetamER60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE602
71205-881-64LevetiracetamER240 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE2402
71205-881-72LevetiracetamER120 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1202
71205-881-78LevetiracetamER180 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1802
71205-881-90LevetiracetamER90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-881-00EA - Each71205-88151af154f-ee52-46a2-bd17-a6ec812bf2fc12021-12-08
71205-881-11EA - Each71205-881b2aceae8-2b2d-4107-8caf-7d5d64f4006312021-12-08
71205-881-30EA - Each71205-881187a4ffc-0cda-4ec8-bf83-a5597eca443f12021-12-08
71205-881-55EA - Each71205-881ac04083c-5df1-4a39-8b72-661060c1449812021-12-08
71205-881-60EA - Each71205-8819e2199d5-395b-433d-9744-f38b9e0334c912021-12-08
71205-881-64EA - Each71205-881c6b941c1-b8f2-444b-aee9-ec39c77e843912021-12-08
71205-881-72EA - Each71205-8813848794e-5101-42c4-806a-bde4190843c112021-12-08
71205-881-78EA - Each71205-881cce41bd7-a3ba-47b3-b2ac-25b15246405b12021-12-08
71205-881-90EA - Each71205-881661f46e1-209f-48bf-8275-f38d700e1c3e12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-881LEVETIRACETAM ER (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 9 package rows20220412_57b9dccb-6ee6-4e89-ab26-4c478e2df2b5.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levetiracetam ERLEVETIRACETAMREMEDYREPACK INC.2d57f22f-fecc-466e-a444-87708c7c2f802025-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205130
application number: ANDA205130
Levetiracetam Extended-ReleaseLEVETIRACETAMScieGen Pharmaceuticals, Inc3e32f341-9926-47a3-a942-d8b9bfa7a55b2024-07-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205130
application number: ANDA205130
Levetiracetam ERLEVETIRACETAMWestminster Pharmaceuticals, LLCc508a392-0603-477d-8a45-3ec5503711112024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205130
application number: ANDA205130
Levetiracetam ERLEVETIRACETAMProficient Rx LPa0ad8200-70c9-4f4f-86c5-4a8c6c9f02232022-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205130
application number: ANDA205130
Levetiracetam ERLEVETIRACETAMProficient Rx LP57b9dccb-6ee6-4e89-ab26-4c478e2df2b52022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205130
application number: ANDA205130
ndc (product): 71205-881

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
807832levETIRAcetam 500 MG 24HR Extended Release Oral TabletPSN57b9dccb-6ee6-4e89-ab26-4c478e2df2b52
846378levETIRAcetam 750 MG 24HR Extended Release Oral TabletPSN57b9dccb-6ee6-4e89-ab26-4c478e2df2b52
80783224 HR levetiracetam 500 MG Extended Release Oral TabletSCD57b9dccb-6ee6-4e89-ab26-4c478e2df2b52
84637824 HR levetiracetam 750 MG Extended Release Oral TabletSCD57b9dccb-6ee6-4e89-ab26-4c478e2df2b52
807832levetiracetam 500 MG 24 HR Extended Release Oral TabletSY57b9dccb-6ee6-4e89-ab26-4c478e2df2b52
846378levetiracetam 750 MG 24 HR Extended Release Oral TabletSY57b9dccb-6ee6-4e89-ab26-4c478e2df2b52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-881-0071205088100100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-881-00) 2021-11-050000-00-00NoNoCurrent
71205-881-11712050881111000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-881-11) 2021-11-050000-00-00NoNoCurrent
71205-881-307120508813030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-881-30) 2021-11-050000-00-00NoNoCurrent
71205-881-5571205088155500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-881-55) 2021-11-050000-00-00NoNoCurrent
71205-881-607120508816060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-881-60) 2021-11-050000-00-00NoNoCurrent
71205-881-6471205088164240 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-881-64) 2021-11-050000-00-00NoNoCurrent
71205-881-7271205088172120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-881-72) 2021-11-050000-00-00NoNoCurrent
71205-881-7871205088178180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-881-78) 2021-11-050000-00-00NoNoCurrent
71205-881-907120508819090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-881-90) 2021-11-050000-00-00NoNoCurrent