LEVETIRACETAM

Product NDC: 70518-4731
Requested package NDC: 70518-4731-0
11-digit product format: 705184731
Labeler code: 70518
Product ID: 70518-4731_5990f8de-5c16-01f0-e063-6294a90a24be
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LEVETIRACETAM
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA203468
Marketing category: ANDA
Marketing start: 2026-08-21
Substance: LEVETIRACETAM
Active strength: 750 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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203468-001	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-21
A203468-002	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-21

Therapeutic equivalence codes#

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

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

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203468-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203468-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-05-21	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203468-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203468-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203468-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203468-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203468-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203468-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203468-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203468-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203468-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203468-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203468-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203468-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203468-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203468-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203468-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203468-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203468-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203468-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203468-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203468-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203468-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203468-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203468-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203468-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203468-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203468-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203468-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203468-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203468-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203468-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203468-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203468-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203468-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203468-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203468-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203468-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203468-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203468-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203468-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203468-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: LEVETIRACETAM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVETIRACETAM	750 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
44YRR34555	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
17969eda-4c85-40a0-9a94-7e4675adf910	Available on FDA.report

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEVETIRACETAM	LEVETIRACETAM	REMEDYREPACK INC.	9bdef24b-c50e-4e6a-8650-59d78009f472	2026-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203468 application number: ANDA203468
LEVETIRACETAM	LEVETIRACETAM	REMEDYREPACK INC.	17969eda-4c85-40a0-9a94-7e4675adf910	2026-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203468 application number: ANDA203468 ndc (package): 70518-4731-0 ndc (product): 70518-4731 ndc11 (package): 70518473100
LEVETIRACETAM	LEVETIRACETAM	Bryant Ranch Prepack	ace53552-d616-45e8-9f99-2f0041d0b430	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203468 application number: ANDA203468
Levetiracetam ER	LEVETIRACETAM ER	Direct_Rx	03c449a1-9b40-a7da-e063-6394a90a984e	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203468 application number: ANDA203468
LEVETIRACETAM	LEVETIRACETAM	Solco healthcare U.S., LLC	bc8644ed-3320-47b5-adf3-8b972bea8abd	2024-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203468 application number: ANDA203468

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
44YRR34555	LEVETIRACETAM	102767-28-2	LEVETIRACETAM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4731-0	70518473100	50 POUCH in 1 BOX (70518-4731-0) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 POUCH (70518-4731-1)	50 pouch	2026-08-21	No	No	Current