Levetiracetam

Product NDC: 66993-101
11-digit product format: 669930101
Labeler code: 66993
Product ID: 66993-101_265f6517-11c1-4af8-9871-ef7fdde464e6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levetiracetam
Dosage form: TABLET, FOR SUSPENSION
Route: ORAL
Labeler: Prasco Laboratories
Application: NDA207958
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2025-01-20
Substance: LEVETIRACETAM
Active strength: 500 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 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N207958-001	SPRITAM	LEVETIRACETAM	250MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31
N207958-002	SPRITAM	LEVETIRACETAM	500MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2015-07-31
N207958-003	SPRITAM	LEVETIRACETAM	750MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31
N207958-004	SPRITAM	LEVETIRACETAM	1GM	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207958-001	11160786	2034-03-14		Drug product	2021-11-30
N207958-001	9339489	2034-03-14	U-1850	Drug product	2017-07-25
N207958-001	9669009	2034-03-14	U-1850		2017-06-28
N207958-001	9669009	2034-03-14	U-2021		2017-06-28
N207958-001	9669009	2034-03-14	U-2022		2017-06-28
N207958-002	11160786	2034-03-14		Drug product	2021-11-30
N207958-002	9339489	2034-03-14	U-1850	Drug product	2016-06-16
N207958-002	9669009	2034-03-14	U-1850		2017-06-28
N207958-002	9669009	2034-03-14	U-2021		2017-06-28
N207958-002	9669009	2034-03-14	U-2022		2017-06-28
N207958-003	11160786	2034-03-14		Drug product	2021-11-30
N207958-003	9339489	2034-03-14	U-1850	Drug product	2016-06-16
N207958-003	9669009	2034-03-14	U-1850		2017-06-28
N207958-003	9669009	2034-03-14	U-2021		2017-06-28
N207958-003	9669009	2034-03-14	U-2022		2017-06-28
N207958-004	11160786	2034-03-14		Drug product	2021-11-30
N207958-004	9339489	2034-03-14	U-1850	Drug product	2016-06-16
N207958-004	9669009	2034-03-14	U-1850		2017-06-28
N207958-004	9669009	2034-03-14	U-2021		2017-06-28
N207958-004	9669009	2034-03-14	U-2022		2017-06-28

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207958-001	SPRITAM	250MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-002	SPRITAM	500MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2015-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-003	SPRITAM	750MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-004	SPRITAM	1GM	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-001	SPRITAM	250MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-002	SPRITAM	500MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2015-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-003	SPRITAM	750MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-004	SPRITAM	1GM	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207958-001	SPRITAM	250MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207958-002	SPRITAM	500MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2015-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207958-003	SPRITAM	750MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207958-004	SPRITAM	1GM	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207958-001	SPRITAM	250MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207958-002	SPRITAM	500MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207958-003	SPRITAM	750MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207958-004	SPRITAM	1GM	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2015-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207958-001	SPRITAM	250MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207958-002	SPRITAM	500MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207958-003	SPRITAM	750MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207958-004	SPRITAM	1GM	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2015-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207958-001	SPRITAM	250MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207958-002	SPRITAM	500MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207958-003	SPRITAM	750MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207958-004	SPRITAM	1GM	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2015-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207958-001	SPRITAM	250MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207958-002	SPRITAM	500MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207958-003	SPRITAM	750MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207958-004	SPRITAM	1GM	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2015-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207958-001	SPRITAM	250MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207958-002	SPRITAM	500MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207958-003	SPRITAM	750MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207958-004	SPRITAM	1GM	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2015-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207958-001	SPRITAM	250MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207958-002	SPRITAM	500MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207958-003	SPRITAM	750MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207958-004	SPRITAM	1GM	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2015-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207958-001	SPRITAM	250MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207958-002	SPRITAM	500MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207958-003	SPRITAM	750MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207958-004	SPRITAM	1GM	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2015-07-31	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 20 · 788 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207958-001	11160786	2034-03-14		Drug product	2021-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-001	9339489	2034-03-14	U-1850	Drug product	2017-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-001	9669009	2034-03-14	U-2021		2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-001	9669009	2034-03-14	U-2022		2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-001	9669009	2034-03-14	U-1850		2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-002	11160786	2034-03-14		Drug product	2021-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-002	9339489	2034-03-14	U-1850	Drug product	2016-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-002	9669009	2034-03-14	U-1850		2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-002	9669009	2034-03-14	U-2022		2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-002	9669009	2034-03-14	U-2021		2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-003	11160786	2034-03-14		Drug product	2021-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-003	9339489	2034-03-14	U-1850	Drug product	2016-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-003	9669009	2034-03-14	U-2021		2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-003	9669009	2034-03-14	U-2022		2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-003	9669009	2034-03-14	U-1850		2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-004	11160786	2034-03-14		Drug product	2021-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-004	9339489	2034-03-14	U-1850	Drug product	2016-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-004	9669009	2034-03-14	U-1850		2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-004	9669009	2034-03-14	U-2021		2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-004	9669009	2034-03-14	U-2022		2017-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-001	11160786	2034-03-14		Drug product	2021-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-001	9339489	2034-03-14	U-1850	Drug product	2017-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-001	9669009	2034-03-14	U-2021		2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-001	9669009	2034-03-14	U-2022		2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-001	9669009	2034-03-14	U-1850		2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-002	11160786	2034-03-14		Drug product	2021-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-002	9339489	2034-03-14	U-1850	Drug product	2016-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-002	9669009	2034-03-14	U-1850		2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-002	9669009	2034-03-14	U-2022		2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-002	9669009	2034-03-14	U-2021		2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-003	11160786	2034-03-14		Drug product	2021-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-003	9339489	2034-03-14	U-1850	Drug product	2016-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-003	9669009	2034-03-14	U-2021		2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-003	9669009	2034-03-14	U-2022		2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-003	9669009	2034-03-14	U-1850		2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-004	11160786	2034-03-14		Drug product	2021-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-004	9339489	2034-03-14	U-1850	Drug product	2016-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-004	9669009	2034-03-14	U-1850		2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-004	9669009	2034-03-14	U-2021		2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-004	9669009	2034-03-14	U-2022		2017-06-28	`31067a03dcf5…`

Additional Listing Data#

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

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
1736045	Internal RxNorm lookup
1736048	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
dd175fa3-1d7a-4542-affd-988ac5bba1db	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
66993-101-51	Levetiracetam	1 in 1 BLISTER PACK	TABLET, FOR SUSPENSION	1		3
66993-101-60	Levetiracetam	60 in 1 CARTON	TABLET, FOR SUSPENSION	60		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-101-51	EA - Each	66993-101	0a13039a-c0c0-4bee-8969-372ba0c65aee	1	2026-03-17
66993-101-60	EA - Each	66993-101	dcd54f32-1258-4ab0-80ac-772bb4dd9e83	1	2026-02-05

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Spritam	LEVETIRACETAM	Aprecia Pharmaceuticals, LLC	be651c31-383f-11e4-916c-0800200c9a66	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207958 application number: NDA207958
Levetiracetam	LEVETIRACETAM	Prasco Laboratories	dd175fa3-1d7a-4542-affd-988ac5bba1db	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207958 application number: NDA207958 ndc (product): 66993-101

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
1736045	levETIRAcetam 250 MG Tablet for Oral Suspension	PSN	dd175fa3-1d7a-4542-affd-988ac5bba1db	3
1736048	levETIRAcetam 500 MG Tablet for Oral Suspension	PSN	dd175fa3-1d7a-4542-affd-988ac5bba1db	3
1736045	levetiracetam 250 MG Tablet for Oral Suspension	SCD	dd175fa3-1d7a-4542-affd-988ac5bba1db	3
1736048	levetiracetam 500 MG Tablet for Oral Suspension	SCD	dd175fa3-1d7a-4542-affd-988ac5bba1db	3
1736045	levetiracetam 250 MG Tablet for Oral Suspension	SY	dd175fa3-1d7a-4542-affd-988ac5bba1db	3
1736048	levetiracetam 500 MG Tablet for Oral Suspension	SY	dd175fa3-1d7a-4542-affd-988ac5bba1db	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
66993-101-51	66993010151	1 in 1 BLISTER PACK					Historical
66993-101-60	66993010160	60 BLISTER PACK in 1 CARTON (66993-101-60) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66993-101-51)	60 blister pack	2026-01-16	No	No	Current