Levetiracetam

Product NDC: 69102-106
11-digit product format: 691020106
Labeler code: 69102
Product ID: 69102-106_c7262ce0-c186-487b-9808-b340d31d8fe4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: TABLET
Route: ORAL
Labeler: OWP Pharmaceuticals, Inc.
Application: ANDA078858
Marketing category: ANDA
Marketing start: 2020-10-28
Substance: LEVETIRACETAM
Active strength: 750 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 43.

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	TE codes	Approval date
A078858-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15
A078858-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15
A078858-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15
A078858-004	LEVETIRACETAM	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A078858-001	AB
A078858-002	AB
A078858-003	AB
A078858-004	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 5 · 172 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
2026-09-14 22:38:34	2026-08	A078858-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078858-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078858-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078858-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078858-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078858-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078858-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078858-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078858-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078858-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078858-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078858-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078858-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078858-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078858-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078858-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078858-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078858-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078858-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078858-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078858-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078858-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078858-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078858-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078858-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078858-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078858-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078858-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078858-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078858-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078858-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078858-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078858-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078858-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078858-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078858-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078858-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078858-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078858-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078858-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078858-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078858-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078858-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078858-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078858-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078858-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078858-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078858-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078858-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078858-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078858-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078858-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078858-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078858-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078858-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078858-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078858-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078858-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078858-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078858-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078858-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078858-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078858-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078858-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078858-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078858-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078858-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078858-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078858-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078858-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078858-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078858-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078858-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078858-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078858-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078858-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078858-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078858-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078858-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078858-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Levetiracetam
Listing expiration: 2026-12-31

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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311288	Internal RxNorm lookup
311289	Internal RxNorm lookup
311290	Internal RxNorm lookup
387003	Internal RxNorm lookup
1875868	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
e662bf5b-c81c-4bcd-ba2e-552df95ca6f9	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
69102-106-01	2022-02-03	C162847	48780-1	d6a99b39-97b2-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use ROWEEPRA (levetiracetam) TABLETS safely and effectively. See full prescribing information for ROWEEPRA TABLETS. ROWEEPRA (levetiracetam) tablets, for oral use Initial U.S. Approval: 1999
69102-106-01	2022-01-28	C162847	48780-1	d6a99b39-97b2-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use ROWEEPRA (levetiracetam) TABLETS safely and effectively. See full prescribing information for ROWEEPRA TABLETS. ROWEEPRA (levetiracetam) 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
69102-106-01	Levetiracetam	120 in 1 BOTTLE	TABLET	120		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69102-106	ROWEEPRA (LEVETIRACETAM) TABLET LEVETIRACETAM TABLET [OWP PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20250525_e662bf5b-c81c-4bcd-ba2e-552df95ca6f9.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	OWP Pharmaceuticals, Inc.	e662bf5b-c81c-4bcd-ba2e-552df95ca6f9	2025-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078858 application number: ANDA078858 ndc (product): 69102-106
Levetiracetam	LEVETIRACETAM	PD-Rx Pharmaceuticals, Inc.	c2177034-e164-453c-be02-1cf91ce27a07	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078858 application number: ANDA078858
Levetiracetam	LEVETIRACETAM	Torrent Pharmaceuticals Limited	6ab24168-058d-496e-9023-da8ee6353eb3	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078858 application number: ANDA078858
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	b738377c-035e-4b2e-9909-0a8fe07aa0fb	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078858 application number: ANDA078858

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
387003	levETIRAcetam 1000 MG Oral Tablet	PSN	e662bf5b-c81c-4bcd-ba2e-552df95ca6f9	5
311288	levETIRAcetam 250 MG Oral Tablet	PSN	e662bf5b-c81c-4bcd-ba2e-552df95ca6f9	5
311289	levETIRAcetam 500 MG Oral Tablet	PSN	e662bf5b-c81c-4bcd-ba2e-552df95ca6f9	5
311290	levETIRAcetam 750 MG Oral Tablet	PSN	e662bf5b-c81c-4bcd-ba2e-552df95ca6f9	5
1875868	Roweepra 250 MG Oral Tablet	PSN	e662bf5b-c81c-4bcd-ba2e-552df95ca6f9	5
1875868	levetiracetam 250 MG Oral Tablet [Roweepra]	SBD	e662bf5b-c81c-4bcd-ba2e-552df95ca6f9	5
387003	levetiracetam 1000 MG Oral Tablet	SCD	e662bf5b-c81c-4bcd-ba2e-552df95ca6f9	5
311288	levetiracetam 250 MG Oral Tablet	SCD	e662bf5b-c81c-4bcd-ba2e-552df95ca6f9	5
311289	levetiracetam 500 MG Oral Tablet	SCD	e662bf5b-c81c-4bcd-ba2e-552df95ca6f9	5
311290	levetiracetam 750 MG Oral Tablet	SCD	e662bf5b-c81c-4bcd-ba2e-552df95ca6f9	5
1875868	Roweepra 250 MG Oral Tablet	SY	e662bf5b-c81c-4bcd-ba2e-552df95ca6f9	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69102-106-01	69102010601	120 TABLET in 1 BOTTLE (69102-106-01)	120 tablet	2020-10-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Roweepra	OWP Pharmaceuticals, Inc. \| Torrent Pharma, Inc. \| Torrent Pharmaceuticals Limited	2025-05-15	HUMAN PRESCRIPTION DRUG LABEL	5