Levetiracetam

Product NDC: 70166-081
Requested package NDC: 70166-081-05
11-digit product format: 701660081
Labeler code: 70166
Product ID: 70166-081_9582e172-999c-7b0d-e053-2995a90a6cb4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: SOLUTION
Route: ORAL
Labeler: Lohxa
Application: ANDA203052
Marketing category: ANDA
Marketing start: 2015-06-11
Marketing end: 0000-00-00
Substance: LEVETIRACETAM
Active strength: 100 mg/mL
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	70166-081	70166-081-05	I	Inactivated by FDA		2026-11-06

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203052-001	LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA		2013-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203052-001	AA

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 2 · 44 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
2026-10-15 13:18:30	2026-09	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A203052-001	AA	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A203052-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203052-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203052-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203052-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203052-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203052-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203052-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203052-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203052-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203052-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203052-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203052-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203052-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203052-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203052-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203052-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203052-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203052-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203052-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203052-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203052-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203052-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203052-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203052-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203052-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203052-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203052-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203052-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203052-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203052-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203052-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203052-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203052-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203052-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203052-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203052-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203052-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203052-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203052-001	AA	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

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

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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
70166-081-05	2023-01-30	C162847	48780-1	f386c64a-46f5-0266-e053-dadaa90a7c1a	LEVETIRACETAM oral solution These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70166-081-05	LevetiracetamLevetiracetam	50 in 1 BOX	SOLUTION	50		1
70166-081-05	LevetiracetamLevetiracetam	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70166-081	LEVETIRACETAM LEVETIRACETAM (LEVETIRACETAM) SOLUTION [LOHXA]	1	Legacy NDC, 2 package rows	20191024_9679202b-2208-43e5-841b-2faab0e516f3.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	American Health Packaging	3be7c30b-f35d-4dde-8bf8-24f67bd70865	2025-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203052 application number: ANDA203052
Levetiracetam	LEVETIRACETAM ORAL	Camber Pharmaceuticals, Inc.	0bc8468f-832c-4e71-95a2-db464d4d54bc	2024-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203052 application number: ANDA203052
Levetiracetam	LEVETIRACETAM	Natco Pharma USA LLC	34af3602-0188-4d2e-904b-2e40000bb45c	2023-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203052 application number: ANDA203052

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
403884	levETIRAcetam 100 MG in 1 mL Oral Solution	PSN	9679202b-2208-43e5-841b-2faab0e516f3	1
403884	levetiracetam 100 MG/ML Oral Solution	SCD	9679202b-2208-43e5-841b-2faab0e516f3	1
403884	levetiracetam 100 MG per 1 ML Oral Solution	SY	9679202b-2208-43e5-841b-2faab0e516f3	1
403884	levetiracetam 1000 MG per 10 ML Oral Solution	SY	9679202b-2208-43e5-841b-2faab0e516f3	1
403884	levetiracetam 1500 MG per 15 ML Oral Solution	SY	9679202b-2208-43e5-841b-2faab0e516f3	1
403884	levetiracetam 500 MG per 5 ML Oral Solution	SY	9679202b-2208-43e5-841b-2faab0e516f3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70166-081-05	70166008105	50 CUP, UNIT-DOSE in 1 BOX (70166-081-05) > 5 mL in 1 CUP, UNIT-DOSE	2019-10-22	0000-00-00	No	No	Current