Levetiracetam

Product NDC: 48433-052
Requested package NDC: 48433-052-20
11-digit product format: 484330052
Labeler code: 48433
Product ID: 48433-052_4f0c308f-3ef4-05f9-e063-6394a90ab87b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levetiracetam
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Safecor Health LLC
Application: ANDA076919
Marketing category: ANDA
Marketing start: 2026-03-18
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 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
A076919-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04
A076919-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04
A076919-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076919-002	AB
A076919-003	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	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 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	A076919-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076919-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076919-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076919-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076919-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076919-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076919-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076919-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076919-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076919-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076919-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076919-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076919-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076919-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076919-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076919-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076919-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076919-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076919-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076919-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076919-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076919-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076919-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076919-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076919-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076919-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076919-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076919-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076919-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076919-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076919-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076919-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076919-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076919-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076919-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076919-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076919-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076919-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076919-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076919-002	AB	1	`4b0b4de00fa7…`

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
e72a7410-13fd-40e4-befb-052d0455e038	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
48433-052-01	Levetiracetam	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		3
48433-052-20	Levetiracetam	100 in 1 CARTON	TABLET, FILM COATED	100		3

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	Cardinal Health 107, LLC	e1b14939-7262-40dc-a334-2b3b72c88d47	2026-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076919 application number: ANDA076919
Levetiracetam	LEVETIRACETAM	Safecor Health LLC	e72a7410-13fd-40e4-befb-052d0455e038	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076919 application number: ANDA076919 ndc (package): 48433-052-20 ndc (product): 48433-052 ndc11 (package): 48433005220
Levetiracetam	LEVETIRACETAM	Mylan Institutional Inc.	08e1bfea-7f3f-42d9-823d-f75080e664ff	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076919 application number: ANDA076919
Levetiracetam	LEVETIRACETAM	Mylan Pharmaceuticals Inc.	0a987d59-560f-4650-96ec-31aec81953b5	2025-04-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076919 application number: ANDA076919

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
311289	levETIRAcetam 500 MG Oral Tablet	PSN	e72a7410-13fd-40e4-befb-052d0455e038	3
311289	levetiracetam 500 MG Oral Tablet	SCD	e72a7410-13fd-40e4-befb-052d0455e038	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
48433-052-20	48433005220	100 BLISTER PACK in 1 CARTON (48433-052-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-052-01)	100 blister pack	2026-03-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levetiracetam	Cardinal Health 107, LLC	2026-09-11	HUMAN PRESCRIPTION DRUG LABEL	1
Levetiracetam	Safecor Health LLC	2026-04-09	HUMAN PRESCRIPTION DRUG LABEL	3