Levetiracetam

Product NDC: 65977-5036
11-digit product format: 659775036
Labeler code: 65977
Product ID: 65977-5036_b9acd365-1b80-4428-bd33-3a5eac814677
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Hetero Drugs Ltd.,
Application: ANDA090515
Marketing category: ANDA
Marketing start: 2010-10-08
Marketing end: 0000-00-00
Substance: LEVETIRACETAM
Active strength: 250 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65977-5036		I	Inactivated by FDA	2026-08-03
excluded package	package	65977-5036	65977-5036-0	I	Inactivated by FDA	2026-08-03
excluded package	package	65977-5036	65977-5036-1	I	Inactivated by FDA	2026-08-03
excluded package	package	65977-5036	65977-5036-2	I	Inactivated by FDA	2026-08-03
excluded package	package	65977-5036	65977-5036-3	I	Inactivated by FDA	2026-08-03
excluded package	package	65977-5036	65977-5036-4	I	Inactivated by FDA	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 3 · 132 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	65977-5036		I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65977-5036	65977-5036-0	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65977-5036	65977-5036-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65977-5036	65977-5036-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65977-5036	65977-5036-4	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65977-5036	65977-5036-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	65977-5036		I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65977-5036	65977-5036-0	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65977-5036	65977-5036-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65977-5036	65977-5036-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65977-5036	65977-5036-4	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65977-5036	65977-5036-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product	65977-5036		I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65977-5036	65977-5036-0	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65977-5036	65977-5036-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65977-5036	65977-5036-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65977-5036	65977-5036-4	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65977-5036	65977-5036-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	65977-5036		I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65977-5036	65977-5036-0	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65977-5036	65977-5036-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65977-5036	65977-5036-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65977-5036	65977-5036-4	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65977-5036	65977-5036-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	65977-5036		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65977-5036	65977-5036-0	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65977-5036	65977-5036-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65977-5036	65977-5036-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65977-5036	65977-5036-4	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65977-5036	65977-5036-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	65977-5036		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65977-5036	65977-5036-0	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65977-5036	65977-5036-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65977-5036	65977-5036-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65977-5036	65977-5036-4	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65977-5036	65977-5036-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	65977-5036		I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65977-5036	65977-5036-0	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65977-5036	65977-5036-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65977-5036	65977-5036-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65977-5036	65977-5036-4	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65977-5036	65977-5036-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	65977-5036		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65977-5036	65977-5036-0	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65977-5036	65977-5036-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65977-5036	65977-5036-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65977-5036	65977-5036-4	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65977-5036	65977-5036-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	65977-5036		I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65977-5036	65977-5036-0	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65977-5036	65977-5036-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65977-5036	65977-5036-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65977-5036	65977-5036-4	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65977-5036	65977-5036-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	65977-5036		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65977-5036	65977-5036-0	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65977-5036	65977-5036-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65977-5036	65977-5036-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65977-5036	65977-5036-4	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65977-5036	65977-5036-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090515-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-10-08
A090515-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-10-08
A090515-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-10-08
A090515-004	LEVETIRACETAM	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-10-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A090515-001	AB
A090515-002	AB
A090515-003	AB
A090515-004	AB

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 5 · 164 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	A090515-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090515-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090515-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090515-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090515-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090515-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090515-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090515-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090515-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090515-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090515-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090515-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090515-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090515-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090515-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090515-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090515-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090515-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090515-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090515-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090515-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090515-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090515-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090515-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090515-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090515-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090515-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090515-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090515-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-10-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090515-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-10-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090515-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-10-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090515-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-10-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090515-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-10-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090515-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-10-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090515-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-10-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090515-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-10-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090515-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-10-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090515-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-10-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090515-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-10-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090515-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-10-08	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090515-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090515-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090515-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090515-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090515-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090515-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090515-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090515-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090515-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090515-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090515-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090515-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090515-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090515-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090515-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090515-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090515-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090515-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090515-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090515-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090515-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090515-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090515-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090515-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090515-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090515-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090515-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090515-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090515-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090515-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090515-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090515-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090515-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090515-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090515-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090515-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090515-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090515-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090515-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090515-004	AB	1	`d06236e962d9…`

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	dfc218c5-672a-420a-b59e-2e0b054e99ad	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	ae405796-1eca-4890-bcb2-e1b07654a24d	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	Injecta Medcial LLC	52fa0eec-3dd9-59ca-e063-6394a90a9791	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	Preferred Pharmaceuticals, Inc.	419b3dba-ae21-4268-ac8b-342aaa609554	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
LEVETIRACETAM	LEVETIRACETAM	DIRECT RX	c3b62114-a590-f4db-e053-2995a90a9d30	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	30f43d3b-c944-4f25-b5d3-009294944962	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	Northwind Health Company, LLC	fc4c72e2-9cba-88d9-e053-6394a90a0426	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	b9597cd5-5745-494a-bd72-93071ed221da	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	PD-Rx Pharmaceuticals, Inc.	792db8dc-177b-4864-8600-12823819082d	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	Quallent Pharmaceuticals Health LLC	3756f052-919c-4817-a56e-1091fd514d9d	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	NorthStar RxLLC	3884cb76-822b-400d-9b24-49c286c9b6f7	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	XLCare Pharmaceuticals Inc.	567f09e6-ccd5-4688-a22b-0bc66a5fe31e	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	bc8b413f-2f07-4e6a-bb8e-a1f2119ae1cf	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	adbcb0f7-0421-47e2-854e-e1cfefb6386f	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515
Levetiracetam	LEVETIRACETAM	Camber Pharmaceuticals, Inc.	63b36274-89f0-42d8-9f09-f9e78e179af4	2024-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090515 application number: ANDA090515

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
76e81f18-c6b9-f226-530a-a6296d5cd5f4	Product name	6	20251106
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
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
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
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
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65977-5036-0	2019-10-29	C162847	48780-1	960f7f55-c9d4-8e05-e053-dbdaa90a074a	Levetiracetam Tablets
65977-5036-1	2019-10-29	C162847	48780-1	960f7f55-c9d4-8e05-e053-dbdaa90a074a	Levetiracetam Tablets
65977-5036-2	2019-10-29	C162847	48780-1	960f7f55-c9d4-8e05-e053-dbdaa90a074a	Levetiracetam Tablets
65977-5036-3	2019-10-29	C162847	48780-1	960f7f55-c9d4-8e05-e053-dbdaa90a074a	Levetiracetam Tablets
65977-5036-4	2019-10-29	C162847	48780-1	960f7f55-c9d4-8e05-e053-dbdaa90a074a	Levetiracetam Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65977-5036-0	Levetiracetam	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
65977-5036-1	Levetiracetam	60 in 1 BOTTLE	TABLET, FILM COATED	60	1
65977-5036-2	Levetiracetam	120 in 1 BOTTLE	TABLET, FILM COATED	120	1
65977-5036-3	Levetiracetam	500 in 1 BOTTLE	TABLET, FILM COATED	500	1
65977-5036-4	Levetiracetam	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVETIRACETAM	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,]	1
LEVETIRACETAM	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,]	1
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,]	1
Polyvinyl Alcohol	INACTIVE INGREDIENT	532B59J990	LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65977-5036	LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,]	1	Legacy NDC, 5 package rows	20110404_b9acd365-1b80-4428-bd33-3a5eac814677.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
387003	levETIRAcetam 1000 MG Oral Tablet	PSN	b9acd365-1b80-4428-bd33-3a5eac814677	1
311288	levETIRAcetam 250 MG Oral Tablet	PSN	b9acd365-1b80-4428-bd33-3a5eac814677	1
311289	levETIRAcetam 500 MG Oral Tablet	PSN	b9acd365-1b80-4428-bd33-3a5eac814677	1
311290	levETIRAcetam 750 MG Oral Tablet	PSN	b9acd365-1b80-4428-bd33-3a5eac814677	1
387003	levetiracetam 1000 MG Oral Tablet	SCD	b9acd365-1b80-4428-bd33-3a5eac814677	1
311288	levetiracetam 250 MG Oral Tablet	SCD	b9acd365-1b80-4428-bd33-3a5eac814677	1
311289	levetiracetam 500 MG Oral Tablet	SCD	b9acd365-1b80-4428-bd33-3a5eac814677	1
311290	levetiracetam 750 MG Oral Tablet	SCD	b9acd365-1b80-4428-bd33-3a5eac814677	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
65977-5036-0	65977503600	30 in 1 BOTTLE	Historical
65977-5036-1	65977503601	60 in 1 BOTTLE	Historical
65977-5036-2	65977503602	120 in 1 BOTTLE	Historical
65977-5036-3	65977503603	500 in 1 BOTTLE	Historical
65977-5036-4	65977503604	1000 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levetiracetam Tablets	Hetero Drugs Ltd., \| Hetero Drugs Limited	2011-01-05	Human Prescription Drug Label	1