Levetiracetam

Product NDC: 60429-349
11-digit product format: 604290349
Labeler code: 60429
Product ID: 60429-349_445d08d0-1f31-1ac0-e063-6394a90a2cdd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA091261
Marketing category: ANDA
Marketing start: 2011-09-12
Substance: LEVETIRACETAM
Active strength: 500 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 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
A091261-001	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-09-12
A091261-002	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091261-001	AB
A091261-002	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	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`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	A091261-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091261-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091261-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091261-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091261-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091261-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091261-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091261-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091261-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091261-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091261-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091261-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091261-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091261-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091261-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091261-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091261-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091261-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091261-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091261-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091261-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091261-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091261-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091261-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091261-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091261-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091261-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091261-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091261-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091261-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091261-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091261-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091261-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091261-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091261-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091261-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091261-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091261-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091261-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091261-002	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
Brand name suffix: Extended-Release
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVETIRACETAM	500 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
807832	Internal RxNorm lookup
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
5dde1889-a217-4493-9a71-9fd39ed04630	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
76e81f18-c6b9-f226-530a-a6296d5cd5f4	Product name	6	20251106
087c9486-f4a9-a565-c6fb-d6fa49f4572a	Product name	6	20230317
525a8d4d-1988-fc3f-e292-27fd384de4f0	Product name	8	20230104
32b651f8-caa7-6882-11c7-54c4ad21796b	Product name	8	20201216
ce453ca5-90cf-41ed-9de4-de519f70a0f2	Product name	2	20160303
66666eb8-1fa6-4a60-bae9-e564e73b4cd5	Product name	1	20150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477	Product name	1	20150410

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60429-349-60	LevetiracetamExtended-Release	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60429-349-60	EA - Each	60429-349	a0381893-526a-48ea-930e-1f5ae3328884	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVETIRACETAM	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
LEVETIRACETAM	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
HYPROMELLOSE 2208 (15000 MPA.S)	INACTIVE INGREDIENT	Z78RG6M2N2	LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60429-349	LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	12	Current NDC, Legacy NDC, 1 package rows	20250406_5dde1889-a217-4493-9a71-9fd39ed04630.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam Extended-Release	LEVETIRACETAM	Golden State Medical Supply, Inc.	5dde1889-a217-4493-9a71-9fd39ed04630	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091261 application number: ANDA091261 ndc (product): 60429-349

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
807832	levETIRAcetam 500 MG 24HR Extended Release Oral Tablet	PSN	5dde1889-a217-4493-9a71-9fd39ed04630	13
846378	levETIRAcetam 750 MG 24HR Extended Release Oral Tablet	PSN	5dde1889-a217-4493-9a71-9fd39ed04630	13
807832	24 HR levetiracetam 500 MG Extended Release Oral Tablet	SCD	5dde1889-a217-4493-9a71-9fd39ed04630	13
846378	24 HR levetiracetam 750 MG Extended Release Oral Tablet	SCD	5dde1889-a217-4493-9a71-9fd39ed04630	13
807832	levetiracetam 500 MG 24 HR Extended Release Oral Tablet	SY	5dde1889-a217-4493-9a71-9fd39ed04630	13
846378	levetiracetam 750 MG 24 HR Extended Release Oral Tablet	SY	5dde1889-a217-4493-9a71-9fd39ed04630	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60429-349-60	60429034960	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60429-349-60)	2012-10-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levetiracetam Extended-Release	Golden State Medical Supply, Inc.	2025-11-24	HUMAN PRESCRIPTION DRUG LABEL	13