levetiracetam

Product NDC: 59746-591
11-digit product format: 597460591
Labeler code: 59746
Product ID: 59746-591_9bcb1710-fc95-49ff-b724-72f5f68ac9b1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam Injection
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Jubilant Cadista Pharmaceuticals Inc.
Application: ANDA206838
Marketing category: ANDA
Marketing start: 2016-06-02
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: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	59746-591		D	Discontinued by firm	2026-08-03
excluded package	package	59746-591	59746-591-10	D	Discontinued by firm	2026-08-03
excluded package	package	59746-591	59746-591-23	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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59746-591-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59746-591-23	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59746-591-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59746-591-23	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59746-591-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59746-591-23	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59746-591-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59746-591-23	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59746-591-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59746-591-23	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59746-591-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59746-591-23	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59746-591-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59746-591-23	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59746-591-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59746-591-23	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59746-591-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59746-591-23	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59746-591-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59746-591-23	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59746-591-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59746-591-23	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59746-591-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59746-591-23	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	59746-591-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	59746-591-23	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	59746-591-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	59746-591-23	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	59746-591-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	59746-591-23	`1332a3947898…`	`d4bfe170f9cd…`

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
A206838-001	LEVETIRACETAM	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS			2016-06-02

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	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2016-06-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2016-06-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2016-06-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2016-06-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2016-06-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2016-06-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2016-06-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2016-06-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206838-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS		2016-06-02	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A206838-001	AP	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206838-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206838-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206838-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206838-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206838-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206838-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206838-001	AP	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
59746-591-10	2026-01-05	These highlights do not include all the information needed to use LEVETIRACETAM INJECTION safely and effectively. See full prescribing information for LEVETIRACETAM INJECTION. LEVETIRACETAM injection for intravenous use Initial U.S. Approval: 1999
59746-591-23	2026-01-05	These highlights do not include all the information needed to use LEVETIRACETAM INJECTION safely and effectively. See full prescribing information for LEVETIRACETAM INJECTION. LEVETIRACETAM injection for intravenous use Initial U.S. Approval: 1999
59746-591-10	2023-01-30	These highlights do not include all the information needed to use LEVETIRACETAM INJECTION safely and effectively. See full prescribing information for LEVETIRACETAM INJECTION. LEVETIRACETAM injection for intravenous use Initial U.S. Approval: 1999
59746-591-23	2023-01-30	These highlights do not include all the information needed to use LEVETIRACETAM INJECTION safely and effectively. See full prescribing information for LEVETIRACETAM INJECTION. LEVETIRACETAM injection for intravenous use Initial U.S. Approval: 1999

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59746-591	LEVETIRACETAM (LEVETIRACETAM INJECTION) INJECTION, SOLUTION, CONCENTRATE [JUBILANT CADISTA PHARMACEUTICALS INC.]	6	Legacy NDC	20210115_0d7d109f-15fc-4d95-ef6a-0e82aa98b30c.zip

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59746-591-10	59746059110	10 VIAL in 1 CARTON (59746-591-10) > 5 mL in 1 VIAL (59746-591-01)	10 vial	2016-06-02	0000-00-00	No	No	Current
59746-591-23	59746059123	25 VIAL in 1 CARTON (59746-591-23) > 5 mL in 1 VIAL (59746-591-01)	25 vial	2016-06-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levetiracetam Injection	Jubilant Cadista Pharmaceuticals Inc. \| Jubilant Generics Limited \| Jubilant HollisterStier LLC	2021-01-13	HUMAN PRESCRIPTION DRUG LABEL	6