Levetiracetam

Product NDC: 35208-032
Requested package NDC: 35208-032-60
11-digit product format: 352080032
Labeler code: 35208
Product ID: 35208-032_b0da0932-ad12-458d-b4de-5d1174cff448
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: IntelliPharmaCeutics Corp.
Application: ANDA204511
Marketing category: ANDA
Marketing start: 2016-10-03
Marketing end: 0000-00-00
Substance: LEVETIRACETAM
Active strength: 750 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	35208-032	35208-032-60	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35208-032	35208-032-60	I	Inactivated by FDA		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35208-032	35208-032-60	I	Inactivated by FDA		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A204511-001	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-02-23
A204511-002	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-02-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204511-001	AB
A204511-002	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	A204511-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204511-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204511-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204511-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204511-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204511-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204511-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204511-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204511-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204511-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204511-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204511-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204511-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204511-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204511-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204511-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204511-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204511-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204511-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204511-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204511-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204511-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204511-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204511-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204511-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204511-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204511-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204511-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204511-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204511-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204511-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204511-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204511-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204511-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204511-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204511-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204511-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204511-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204511-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204511-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-23	`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	A204511-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204511-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204511-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204511-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204511-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204511-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204511-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204511-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204511-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204511-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204511-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204511-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204511-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204511-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204511-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204511-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204511-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204511-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204511-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204511-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204511-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204511-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204511-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204511-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204511-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204511-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204511-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204511-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204511-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204511-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204511-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204511-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204511-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204511-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204511-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204511-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204511-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204511-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204511-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204511-002	AB	1	`782e0a99824c…`

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, Related label table
NDC	Effective	Related label
35208-032-10	2025-07-29	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
35208-032-60	2025-07-29	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
35208-032-10	2024-01-30	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
35208-032-60	2024-01-30	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
35208-032-10	LevetiracetamExtended-release	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000		5
35208-032-60	LevetiracetamExtended-release	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35208-032	LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [INTELLIPHARMACEUTICS CORP.]	5	Legacy NDC, 2 package rows	20171211_02727941-c5ea-4f85-beb4-2a00eec73dd0.zip

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	02727941-c5ea-4f85-beb4-2a00eec73dd0	5
846378	levETIRAcetam 750 MG 24HR Extended Release Oral Tablet	PSN	02727941-c5ea-4f85-beb4-2a00eec73dd0	5
807832	24 HR levetiracetam 500 MG Extended Release Oral Tablet	SCD	02727941-c5ea-4f85-beb4-2a00eec73dd0	5
846378	24 HR levetiracetam 750 MG Extended Release Oral Tablet	SCD	02727941-c5ea-4f85-beb4-2a00eec73dd0	5
807832	levetiracetam 500 MG 24 HR Extended Release Oral Tablet	SY	02727941-c5ea-4f85-beb4-2a00eec73dd0	5
846378	levetiracetam 750 MG 24 HR Extended Release Oral Tablet	SY	02727941-c5ea-4f85-beb4-2a00eec73dd0	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
35208-032-60	35208003260	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (35208-032-60)	2016-10-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levetiracetam Extended-release	IntelliPharmaCeutics Corp. \| Aurobindo Pharma Ltd.	2017-12-06	Human Prescription Drug Label	5