Levetiracetam

Product NDC: 76282-247
Requested package NDC: 76282-247-12
11-digit product format: 762820247
Labeler code: 76282
Product ID: 76282-247_b044e723-e969-45fa-a4e6-159bfb65267a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: TABLET
Route: ORAL
Labeler: Exelan Pharmaceuticals, Inc.
Application: ANDA078234
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: 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078234-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15
A078234-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15
A078234-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078234-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078234-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078234-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078234-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078234-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078234-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078234-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078234-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078234-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078234-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078234-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078234-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078234-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078234-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078234-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078234-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078234-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078234-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078234-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078234-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078234-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078234-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078234-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078234-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078234-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078234-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078234-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078234-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078234-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078234-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078234-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078234-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078234-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078234-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078234-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078234-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078234-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078234-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078234-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078234-001	AB	1	`6a51e52b5d6a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Levetiracetam
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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311288	Internal RxNorm lookup
311289	Internal RxNorm lookup
311290	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
28c0e61e-1af9-410a-9fa9-b71bf99a776b	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
76282-247-12	Levetiracetam	120 in 1 BOTTLE	TABLET	120		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76282-247-12	EA - Each	76282-247	fcaf1d4c-a7bf-4d9f-808b-c7d5adec7a5a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVETIRACETAM	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM TABLET [EXELAN PHARMACEUTICALS, INC.]	1
LEVETIRACETAM	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM TABLET [EXELAN PHARMACEUTICALS, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LEVETIRACETAM TABLET [EXELAN PHARMACEUTICALS, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LEVETIRACETAM TABLET [EXELAN PHARMACEUTICALS, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LEVETIRACETAM TABLET [EXELAN PHARMACEUTICALS, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVETIRACETAM TABLET [EXELAN PHARMACEUTICALS, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LEVETIRACETAM TABLET [EXELAN PHARMACEUTICALS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVETIRACETAM TABLET [EXELAN PHARMACEUTICALS, INC.]	1
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	LEVETIRACETAM TABLET [EXELAN PHARMACEUTICALS, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LEVETIRACETAM TABLET [EXELAN PHARMACEUTICALS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVETIRACETAM TABLET [EXELAN PHARMACEUTICALS, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEVETIRACETAM TABLET [EXELAN PHARMACEUTICALS, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LEVETIRACETAM TABLET [EXELAN PHARMACEUTICALS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVETIRACETAM TABLET [EXELAN PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76282-247	LEVETIRACETAM TABLET [EXELAN PHARMACEUTICALS, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20181202_28c0e61e-1af9-410a-9fa9-b71bf99a776b.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	LEVETIRACETAM	Exelan Pharmaceuticals, Inc.	28c0e61e-1af9-410a-9fa9-b71bf99a776b	2018-11-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078234 application number: ANDA078234 ndc (package): 76282-247-12 ndc (product): 76282-247 ndc11 (package): 76282024712

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
311288	levETIRAcetam 250 MG Oral Tablet	PSN	28c0e61e-1af9-410a-9fa9-b71bf99a776b	4
311289	levETIRAcetam 500 MG Oral Tablet	PSN	28c0e61e-1af9-410a-9fa9-b71bf99a776b	4
311290	levETIRAcetam 750 MG Oral Tablet	PSN	28c0e61e-1af9-410a-9fa9-b71bf99a776b	4
311288	levetiracetam 250 MG Oral Tablet	SCD	28c0e61e-1af9-410a-9fa9-b71bf99a776b	4
311289	levetiracetam 500 MG Oral Tablet	SCD	28c0e61e-1af9-410a-9fa9-b71bf99a776b	4
311290	levetiracetam 750 MG Oral Tablet	SCD	28c0e61e-1af9-410a-9fa9-b71bf99a776b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76282-247-12	76282024712	120 TABLET in 1 BOTTLE (76282-247-12)	120 tablet	2009-01-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levetiracetam	Exelan Pharmaceuticals, Inc. \| InvaGen Pharmaceuticals, Inc	2018-11-29	HUMAN PRESCRIPTION DRUG LABEL	4