Levetiracetam

Product NDC: 17856-0241
11-digit product format: 178560241
Labeler code: 17856
Product ID: 17856-0241_d20c3cb8-9bc7-4f84-8310-b9964ceb9c60
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levetiracetam
Dosage form: SOLUTION
Route: ORAL
Labeler: Atlantic Biologicals Corps.
Application: ANDA090601
Marketing category: ANDA
Marketing start: 2012-02-28
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	17856-0241		I	Inactivated by FDA	2026-10-05
excluded package	package	17856-0241	17856-0241-1	I	Inactivated by FDA	2026-10-05
excluded package	package	17856-0241	17856-0241-3	I	Inactivated by FDA	2026-10-05
excluded package	package	17856-0241	17856-0241-5	I	Inactivated by FDA	2026-10-05

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 2 · 76 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	17856-0241-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0241-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0241-5	`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	17856-0241-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0241-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0241-5	`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	17856-0241-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0241-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0241-5	`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	17856-0241-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0241-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0241-5	`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	17856-0241-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0241-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0241-5	`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	17856-0241-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0241-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0241-5	`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	17856-0241-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0241-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0241-5	`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	17856-0241-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-0241-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-0241-5	`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	17856-0241-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-0241-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-0241-5	`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	17856-0241-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-0241-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-0241-5	`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	17856-0241-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-0241-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-0241-5	`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	17856-0241-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-0241-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-0241-5	`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	17856-0241-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17856-0241-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17856-0241-5	`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	17856-0241-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17856-0241-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17856-0241-5	`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	17856-0241-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17856-0241-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17856-0241-5	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090601-001	LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL			2012-02-28

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 · 43 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	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL		2012-02-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL		2012-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL		2012-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL		2012-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL		2012-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL		2012-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL		2012-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL		2012-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL		2012-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL		2012-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL		2012-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL		2012-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL		2012-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL		2012-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL		2012-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL		2012-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090601-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-02-28	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090601-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090601-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090601-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090601-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090601-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090601-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090601-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090601-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090601-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090601-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090601-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090601-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090601-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090601-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090601-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090601-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090601-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090601-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090601-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090601-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090601-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090601-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090601-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090601-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090601-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090601-001	AA	1	`cb3db0bc1861…`

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
087c9486-f4a9-a565-c6fb-d6fa49f4572a	Product name	6	20230317
525a8d4d-1988-fc3f-e292-27fd384de4f0	Product name	8	20230104
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
32b651f8-caa7-6882-11c7-54c4ad21796b	Product name	8	20201216
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
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
17856-0241-1	2021-01-29	C162847	48780-1	ba0f9c33-51b0-a910-e053-dadaa90a0b85	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. Levetiracetam Oral Solution Initial U.S. Approval: 1999
17856-0241-3	2021-01-29	C162847	48780-1	ba0f9c33-51b0-a910-e053-dadaa90a0b85	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. Levetiracetam Oral Solution Initial U.S. Approval: 1999
17856-0241-5	2021-01-29	C162847	48780-1	ba0f9c33-51b0-a910-e053-dadaa90a0b85	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. Levetiracetam Oral Solution Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17856-0241-1	Levetiracetam	10 mL in 1 CUP	SOLUTION	10	11
17856-0241-3	Levetiracetam	15 mL in 1 CUP	SOLUTION	15	11
17856-0241-5	Levetiracetam	5 mL in 1 CUP	SOLUTION	5	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17856-0241-5	ML - Milliliter	17856-0241	ca13624f-b28f-4ddf-b2cd-5870c6fb8433	1	2014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
levetiracetam	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
levetiracetam	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
AMMONIUM GLYCYRRHIZATE	INACTIVE INGREDIENT	3VRD35U26C	LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
MALTITOL	INACTIVE INGREDIENT	D65DG142WK	LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0241	LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS.]	11	Legacy NDC, 3 package rows	20190917_0d0fa6a4-0fca-4114-b5a5-77f9efac7fe2.zip

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	0d0fa6a4-0fca-4114-b5a5-77f9efac7fe2	11
403884	levetiracetam 100 MG/ML Oral Solution	SCD	0d0fa6a4-0fca-4114-b5a5-77f9efac7fe2	11
403884	levetiracetam 100 MG per 1 ML Oral Solution	SY	0d0fa6a4-0fca-4114-b5a5-77f9efac7fe2	11
403884	levetiracetam 1000 MG per 10 ML Oral Solution	SY	0d0fa6a4-0fca-4114-b5a5-77f9efac7fe2	11
403884	levetiracetam 1500 MG per 15 ML Oral Solution	SY	0d0fa6a4-0fca-4114-b5a5-77f9efac7fe2	11
403884	levetiracetam 500 MG per 5 ML Oral Solution	SY	0d0fa6a4-0fca-4114-b5a5-77f9efac7fe2	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
17856-0241-1	17856024101	10 mL in 1 CUP	10 ml	Historical
17856-0241-3	17856024103	15 mL in 1 CUP	15 ml	Historical
17856-0241-5	17856024105	5 mL in 1 CUP	5 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levetiracetam	Atlantic Biologicals Corps. \| Atlantic Biologicals Corps	2019-09-16	HUMAN PRESCRIPTION DRUG LABEL	11