Levetiracetam

Product NDC: 68001-113
11-digit product format: 680010113
Labeler code: 68001
Product ID: 68001-113_4c3170a9-0612-f257-e063-6294a90a1f4a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: BluePoint Laboratories
Application: ANDA091399
Marketing category: ANDA
Marketing start: 2014-02-13
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091399-001	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-09-12
A091399-002	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
A091399-001	AB
A091399-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091399-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091399-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091399-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091399-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091399-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091399-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091399-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091399-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091399-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091399-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091399-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091399-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091399-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091399-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091399-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091399-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091399-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091399-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091399-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091399-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091399-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091399-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091399-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091399-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091399-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091399-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091399-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091399-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091399-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091399-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091399-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091399-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091399-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091399-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091399-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091399-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091399-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091399-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091399-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091399-002	AB	1	`782e0a99824c…`

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
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
402b488c-1733-4bf7-a7a8-b60805b022c9	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
68001-113-06	Levetiracetam	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60		24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-113-06	EA - Each	68001-113	d1e8ccd8-8414-4122-898d-6eb36d946606	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVETIRACETAM	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	7
LEVETIRACETAM	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	7
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	LEVETIRACETAM TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	7
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	LEVETIRACETAM TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LEVETIRACETAM TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	7
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	LEVETIRACETAM TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	7
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	LEVETIRACETAM TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVETIRACETAM TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	7
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LEVETIRACETAM TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	7
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	LEVETIRACETAM TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LEVETIRACETAM TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	7
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LEVETIRACETAM TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVETIRACETAM TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LEVETIRACETAM TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVETIRACETAM TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-113	LEVETIRACETAM TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	23	Current NDC, Legacy NDC, 1 package rows	20250410_402b488c-1733-4bf7-a7a8-b60805b022c9.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	BluePoint Laboratories	402b488c-1733-4bf7-a7a8-b60805b022c9	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091399 application number: ANDA091399 ndc (product): 68001-113
Levetiracetam	LEVETIRACETAM	Lupin Pharmaceuticals, Inc.	18648f51-a37c-41e1-b451-123bc0cf5446	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091399 application number: ANDA091399

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	402b488c-1733-4bf7-a7a8-b60805b022c9	24
846378	levETIRAcetam 750 MG 24HR Extended Release Oral Tablet	PSN	402b488c-1733-4bf7-a7a8-b60805b022c9	24
807832	24 HR levetiracetam 500 MG Extended Release Oral Tablet	SCD	402b488c-1733-4bf7-a7a8-b60805b022c9	24
846378	24 HR levetiracetam 750 MG Extended Release Oral Tablet	SCD	402b488c-1733-4bf7-a7a8-b60805b022c9	24
807832	levetiracetam 500 MG 24 HR Extended Release Oral Tablet	SY	402b488c-1733-4bf7-a7a8-b60805b022c9	24
846378	levetiracetam 750 MG 24 HR Extended Release Oral Tablet	SY	402b488c-1733-4bf7-a7a8-b60805b022c9	24

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-113-06	68001011306	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-113-06)	2014-02-13	0000-00-00	No	No	Current