LEVETIRACETAM

Product NDC: 81665-100
11-digit product format: 816650100
Labeler code: 81665
Product ID: 81665-100_c50830af-76fa-476a-a88d-50f38f9ecc42
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LEVETIRACETAM
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Omnivium Pharmaceuticals LLC
Application: ANDA212688
Marketing category: ANDA
Marketing start: 2020-06-11
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 42.

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
A212688-001	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2020-06-11
A212688-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2023-05-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212688-001	AB
A212688-002	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 2 · 61 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
2026-08-18 06:07:40	2026-07	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 59 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212688-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212688-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212688-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212688-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212688-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212688-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212688-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212688-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212688-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212688-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212688-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212688-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212688-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212688-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212688-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212688-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212688-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212688-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212688-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212688-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212688-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212688-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212688-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212688-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212688-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212688-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212688-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212688-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212688-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212688-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212688-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212688-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212688-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212688-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212688-001	AB	1	`782e0a99824c…`
2020-12-22 03:56 UTC	2020-12	A212688-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212688-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212688-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212688-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212688-001	AB	1	`1c564ffb4f44…`

Additional Listing Data#

Finished product: Yes
Brand name base: LEVETIRACETAM
Brand name suffix: Extended-release
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 · 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
1a31134d-6b63-4d14-8445-0ed132e6c88d	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
81665-100-60	2023-08-26	C162847	48780-1	f386c649-f8c3-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use LEVETIRACETAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM EXTENDED-RELEASE TABLETS. LEVETIRACETAM extended-release tablets, for oral use Initial U.S. Approval: 1999
81665-100-60	2023-01-30	C162847	48780-1	f386c649-f8c3-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use LEVETIRACETAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM EXTENDED-RELEASE TABLETS. LEVETIRACETAM extended-release tablets, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81665-100-12	LEVETIRACETAMExtended-release	120 in 1 BOTTLE	TABLET, EXTENDED RELEASE	120		11
81665-100-60	LEVETIRACETAMExtended-release	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81665-100-60	EA - Each	81665-100	82a45fa8-fa6b-453f-886f-7f81e2d1e775	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81665-100	LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [OMNIVIUM PHARMACEUTICALS LLC]	10	Current NDC, Legacy NDC, 2 package rows	20240528_1a31134d-6b63-4d14-8445-0ed132e6c88d.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	Omnivium Pharmaceuticals LLC	1a31134d-6b63-4d14-8445-0ed132e6c88d	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212688 application number: ANDA212688 ndc (product): 81665-100

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	1a31134d-6b63-4d14-8445-0ed132e6c88d	11
846378	levETIRAcetam 750 MG 24HR Extended Release Oral Tablet	PSN	1a31134d-6b63-4d14-8445-0ed132e6c88d	11
807832	24 HR levetiracetam 500 MG Extended Release Oral Tablet	SCD	1a31134d-6b63-4d14-8445-0ed132e6c88d	11
846378	24 HR levetiracetam 750 MG Extended Release Oral Tablet	SCD	1a31134d-6b63-4d14-8445-0ed132e6c88d	11
807832	levetiracetam 500 MG 24 HR Extended Release Oral Tablet	SY	1a31134d-6b63-4d14-8445-0ed132e6c88d	11
846378	levetiracetam 750 MG 24 HR Extended Release Oral Tablet	SY	1a31134d-6b63-4d14-8445-0ed132e6c88d	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
81665-100-12	81665010012	120 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-100-12)	2022-10-24		No	No	Current
81665-100-60	81665010060	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-100-60)	2020-06-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LEVETIRACETAM Extended-release	Omnivium Pharmaceuticals LLC \| Changzhou Pharmaceutical Factory	2026-01-16	Human Prescription Drug Label	11