Levetiracetam

Product NDC: 70518-1772
Requested package NDC: 70518-1772-1
11-digit product format: 705181772
Labeler code: 70518
Product ID: 70518-1772_584c25e8-0c93-3704-e063-6294a90ac7d9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA078154
Marketing category: ANDA
Marketing start: 2019-01-02
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

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	70518-1772	70518-1772-1	D	Discontinued by firm		2026-10-05

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	70518-1772	70518-1772-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-1772	70518-1772-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078154-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15
A078154-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15
A078154-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078154-001	AB
A078154-002	AB
A078154-003	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 4 · 129 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	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A078154-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078154-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078154-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078154-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078154-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078154-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078154-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078154-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078154-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078154-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078154-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078154-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078154-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078154-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078154-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078154-001	AB	1	`301d65b070ca…`

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: 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311289	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
a1b28234-1f7c-40bf-80a7-6cc98b3839fe	Available on FDA.report

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-1772	LEVETIRACETAM TABLET, FILM COATED [REMEDYREPACK INC.]	9	Current NDC, Legacy NDC	20250228_a1b28234-1f7c-40bf-80a7-6cc98b3839fe.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	a1b28234-1f7c-40bf-80a7-6cc98b3839fe	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154 ndc (package): 70518-1772-1 ndc (product): 70518-1772 ndc11 (package): 70518177201
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	1c26c0ad-9d37-45c5-9091-849509f4fc01	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	90e01877-abcb-4697-a7ed-9afe5ee77050	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	PD-Rx Pharmaceuticals, Inc.	c4b2da6a-ed50-4a54-90bd-32f76b178736	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	Lupin Pharmaceuticals, Inc.	df661166-325d-4071-9bc1-f7bf992996d2	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	24f815ef-58e6-42b9-8137-adcd6c382aa6	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	9e3171c9-70e2-4725-8aca-c7f83773940d	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	Preferred Pharmaceuticals, Inc.	e31c6830-4647-4481-b4f1-494a52c48b1b	2025-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	Proficient Rx LP	6bdbc193-d86b-4bd5-8e88-4ea964d2cdde	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
44YRR34555	LEVETIRACETAM	102767-28-2	LEVETIRACETAM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-1772-1	70518177201	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1772-1)	2022-10-10	0000-00-00	No	No	Current