Levetiracetam

Product NDC: 17856-0685
11-digit product format: 178560685
Labeler code: 17856
Product ID: 17856-0685_21ec5b7c-90dc-428e-ab27-c624bb2105cc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: SOLUTION
Route: ORAL
Labeler: Atlantic Biologicals Corps
Application: ANDA090992
Marketing category: ANDA
Marketing start: 2009-10-27
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	17856-0685		I	Inactivated by FDA	2026-10-05
excluded package	package	17856-0685	17856-0685-1	I	Inactivated by FDA	2026-10-05
excluded package	package	17856-0685	17856-0685-5	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 1 · 57 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	17856-0685-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0685-5	`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	17856-0685-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0685-5	`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	17856-0685-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0685-5	`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	17856-0685-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0685-5	`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	17856-0685-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0685-5	`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	17856-0685-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0685-5	`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	17856-0685-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0685-5	`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	17856-0685-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-0685-5	`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	17856-0685-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-0685-5	`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	17856-0685-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-0685-5	`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	17856-0685-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-0685-5	`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	17856-0685-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-0685-5	`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	17856-0685-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17856-0685-5	`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	17856-0685-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17856-0685-5	`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	17856-0685-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17856-0685-5	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	17856-0685-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	17856-0685-5	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	17856-0685-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	17856-0685-5	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	17856-0685-1	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	17856-0685-5	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	17856-0685-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	17856-0685-5	`8dfbde2a14a4…`	`c9ff85d89658…`

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
A090992-001	LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA		2009-10-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090992-001	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 · 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	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090992-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-10-27	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090992-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090992-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090992-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090992-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090992-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090992-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090992-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090992-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090992-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090992-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090992-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090992-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090992-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090992-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090992-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090992-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090992-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090992-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090992-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090992-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090992-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090992-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090992-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090992-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090992-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090992-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090992-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090992-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090992-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090992-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090992-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090992-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090992-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090992-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090992-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090992-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090992-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090992-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090992-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090992-001	AA	1	`f41ea6bd6efb…`

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
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
17856-0685-1	2021-01-29	C162847	48780-1	ba0f9c33-5258-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use levetiracetam oral solution, USP safely and effectively. See full prescribing information for levetiracetam oral solution, USP. Levetiracetam oral solution, USP Initial U.S. Approval: 1999
17856-0685-5	2021-01-29	C162847	48780-1	ba0f9c33-5258-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use levetiracetam oral solution, USP safely and effectively. See full prescribing information for levetiracetam oral solution, 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
17856-0685-1	Levetiracetam	10 mL in 1 CUP	SOLUTION	10		4
17856-0685-5	Levetiracetam	5 mL in 1 CUP	SOLUTION	5		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVETIRACETAM	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
LEVETIRACETAM	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
MALTITOL	INACTIVE INGREDIENT	D65DG142WK	LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0685	LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	4	Legacy NDC, 2 package rows	20191017_a70be430-21fa-49a4-84c1-134621ee2f4f.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	Amneal Pharmaceuticals LLC	5c4877cc-52bc-4f98-a995-0aa9439da742	2024-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090992 application number: ANDA090992

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	a70be430-21fa-49a4-84c1-134621ee2f4f	4
403884	levetiracetam 100 MG/ML Oral Solution	SCD	a70be430-21fa-49a4-84c1-134621ee2f4f	4
403884	levetiracetam 100 MG per 1 ML Oral Solution	SY	a70be430-21fa-49a4-84c1-134621ee2f4f	4
403884	levetiracetam 1000 MG per 10 ML Oral Solution	SY	a70be430-21fa-49a4-84c1-134621ee2f4f	4
403884	levetiracetam 1500 MG per 15 ML Oral Solution	SY	a70be430-21fa-49a4-84c1-134621ee2f4f	4
403884	levetiracetam 500 MG per 5 ML Oral Solution	SY	a70be430-21fa-49a4-84c1-134621ee2f4f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
17856-0685-1	17856068501	10 mL in 1 CUP	10 ml	Historical
17856-0685-5	17856068505	5 mL in 1 CUP	5 ml	Historical