LEVETIRACETAM

Product NDC: 10135-695
Requested package NDC: 10135-695-08
11-digit product format: 101350695
Labeler code: 10135
Product ID: 10135-695_f519081c-230f-4a77-a80d-28e2f7d163df
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levetiracetam
Dosage form: SOLUTION
Route: ORAL
Labeler: Marlex Pharmaceuticals Inc
Application: ANDA078582
Marketing category: ANDA
Marketing start: 2020-03-01
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: 2021-12-31
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	10135-695	10135-695-08	I	Inactivated by FDA		2026-08-11

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 · 18 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…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078582-001	LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL			2009-01-15

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 · 41 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	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL		2009-01-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL		2009-01-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL		2009-01-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL		2009-01-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078582-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078582-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078582-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078582-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078582-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078582-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078582-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078582-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078582-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078582-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078582-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078582-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078582-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078582-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078582-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078582-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078582-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078582-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A078582-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078582-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078582-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078582-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078582-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078582-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078582-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078582-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078582-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078582-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078582-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078582-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078582-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078582-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078582-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078582-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078582-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078582-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078582-001	AA	1	`cb3db0bc1861…`

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
10135-695-08	2022-01-28	C162847	48780-1	d6a99b39-d5df-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use LEVETIRACETAM o ral s olution, USP safely and effectively. See full prescribing information for L EVETIRACETAM o ral s olution, USP . LEVETIRACETAM oral solution, USP Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10135-695-08	LEVETIRACETAM	473 mL in 1 BOTTLE, PLASTIC	SOLUTION	473		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-695-08	ML - Milliliter	10135-695	8e9458f5-1e9d-47a5-9a2f-e053331d6d75	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-695	LEVETIRACETAM SOLUTION [MARLEX PHARMACEUTICALS INC]	1	Legacy NDC, 1 package rows	20200404_59eb1819-529d-466e-967b-50e7ab1988de.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	f7c96494-6cb2-4d00-8c5a-5bec4e0c70c0	2024-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078582 application number: ANDA078582
Levetiracetam	LEVETIRACETAM	Patrin Pharma, Inc.	49117cee-a96c-4593-91a7-8a133e3f0939	2024-02-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078582 application number: ANDA078582

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	59eb1819-529d-466e-967b-50e7ab1988de	1
403884	levetiracetam 100 MG/ML Oral Solution	SCD	59eb1819-529d-466e-967b-50e7ab1988de	1
403884	levetiracetam 100 MG per 1 ML Oral Solution	SY	59eb1819-529d-466e-967b-50e7ab1988de	1
403884	levetiracetam 1000 MG per 10 ML Oral Solution	SY	59eb1819-529d-466e-967b-50e7ab1988de	1
403884	levetiracetam 1500 MG per 15 ML Oral Solution	SY	59eb1819-529d-466e-967b-50e7ab1988de	1
403884	levetiracetam 500 MG per 5 ML Oral Solution	SY	59eb1819-529d-466e-967b-50e7ab1988de	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10135-695-08	10135069508	473 mL in 1 BOTTLE, PLASTIC (10135-695-08)	473 ml	2020-03-01	0000-00-00	No	No	Current