Levetiracetam

Product NDC: 70518-1901
11-digit product format: 705181901
Labeler code: 70518
Product ID: 70518-1901_4987ad82-cd46-45b0-e063-6394a90af127
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA090515
Marketing category: ANDA
Marketing start: 2019-02-22
Substance: LEVETIRACETAM
Active strength: 1000 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	70518-1901	70518-1901-0	D	Discontinued by firm		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	70518-1901	70518-1901-0	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-1901	70518-1901-0	D	Discontinued by firm		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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090515-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-10-08
A090515-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-10-08
A090515-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-10-08
A090515-004	LEVETIRACETAM	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-10-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090515-001	AB
A090515-002	AB
A090515-003	AB
A090515-004	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 · 164 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	A090515-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090515-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090515-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090515-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090515-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090515-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090515-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090515-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090515-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090515-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090515-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090515-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090515-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090515-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090515-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090515-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090515-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090515-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090515-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090515-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090515-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090515-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090515-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090515-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090515-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090515-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090515-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090515-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090515-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-10-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090515-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-10-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090515-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-10-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090515-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-10-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090515-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-10-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090515-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-10-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090515-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-10-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090515-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-10-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090515-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-10-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090515-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-10-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090515-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-10-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090515-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-10-08	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A090515-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090515-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090515-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090515-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090515-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090515-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090515-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090515-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090515-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090515-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090515-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090515-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090515-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090515-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090515-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090515-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090515-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090515-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090515-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090515-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090515-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090515-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090515-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090515-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090515-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090515-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090515-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090515-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090515-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090515-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090515-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090515-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090515-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090515-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090515-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090515-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090515-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090515-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090515-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090515-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Levetiracetam
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVETIRACETAM	1000 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
387003	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
ae405796-1eca-4890-bcb2-e1b07654a24d	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
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
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
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
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70518-1901-0	2023-03-07	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
70518-1901-0	2023-03-07	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
70518-1901-1	2023-03-07	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
70518-1901-1	2023-03-07	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
70518-1901-0	2023-01-30	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
70518-1901-0	2023-01-30	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
70518-1901-1	2023-01-30	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
70518-1901-1	2023-01-30	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70518-1901-0	Levetiracetam	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	14
70518-1901-1	Levetiracetam	30 in 1 BOX	TABLET, FILM COATED	30	14
70518-1901-2	Levetiracetam	1 in 1 POUCH	TABLET, FILM COATED	1	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-1901	LEVETIRACETAM TABLET, FILM COATED [REMEDYREPACK INC.]	12	Current NDC, Legacy NDC, 3 package rows	20250424_ae405796-1eca-4890-bcb2-e1b07654a24d.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	dfc218c5-672a-420a-b59e-2e0b054e99ad	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	ae405796-1eca-4890-bcb2-e1b07654a24d	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515 ndc (product): 70518-1901
Levetiracetam	LEVETIRACETAM	Injecta Medcial LLC	52fa0eec-3dd9-59ca-e063-6394a90a9791	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	Preferred Pharmaceuticals, Inc.	419b3dba-ae21-4268-ac8b-342aaa609554	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
LEVETIRACETAM	LEVETIRACETAM	DIRECT RX	c3b62114-a590-f4db-e053-2995a90a9d30	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	30f43d3b-c944-4f25-b5d3-009294944962	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	Northwind Health Company, LLC	fc4c72e2-9cba-88d9-e053-6394a90a0426	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	b9597cd5-5745-494a-bd72-93071ed221da	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	PD-Rx Pharmaceuticals, Inc.	792db8dc-177b-4864-8600-12823819082d	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	Quallent Pharmaceuticals Health LLC	3756f052-919c-4817-a56e-1091fd514d9d	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	NorthStar RxLLC	3884cb76-822b-400d-9b24-49c286c9b6f7	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	XLCare Pharmaceuticals Inc.	567f09e6-ccd5-4688-a22b-0bc66a5fe31e	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	bc8b413f-2f07-4e6a-bb8e-a1f2119ae1cf	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	adbcb0f7-0421-47e2-854e-e1cfefb6386f	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	Camber Pharmaceuticals, Inc.	63b36274-89f0-42d8-9f09-f9e78e179af4	2024-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515

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	ae405796-1eca-4890-bcb2-e1b07654a24d	14
387003	levetiracetam 1000 MG Oral Tablet	SCD	ae405796-1eca-4890-bcb2-e1b07654a24d	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-1901-0	70518190100	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1901-0)		2019-02-22	0000-00-00	No	No	Current
70518-1901-1	70518190101	30 POUCH in 1 BOX (70518-1901-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-1901-2)	30 pouch	2021-08-04	0000-00-00	No	No	Current
70518-1901-2	70518190102	1 in 1 POUCH						Historical
70518-1901-3	70518190103	50 POUCH in 1 BOX (70518-1901-3) / 1 TABLET, FILM COATED in 1 POUCH (70518-1901-2)	50 pouch	2026-07-07		0		Current