Keppra

Product NDC: 65084-461
11-digit product format: 650840461
Labeler code: 65084
Product ID: 65084-461_194d444f-6e9a-46fb-a4d4-750f93dfc80e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levetiracetam
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Mckesson Rxpak Inc
Application: NDA022285
Marketing category: NDA
Marketing start: 2009-04-01
Marketing end: 0000-00-00
Substance: LEVETIRACETAM
Active strength: 750 mg/1
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

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		Y	Unknown FDA exclusion code: Y	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	65084-461-20	Y	Unknown FDA exclusion code: Y	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	65084-461-20	E	Excluded after deficient or non-compliant submission was not corrected	`9bebd1f3094a…`	`5416666fcb17…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022285-001	KEPPRA XR	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12
N022285-002	KEPPRA XR	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N022285-001	AB
N022285-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022285-001	7858122	2028-09-17		Drug product	2011-01-07
N022285-002	7858122	2028-09-17		Drug product

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	N022285-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022285-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022285-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022285-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022285-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022285-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022285-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022285-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022285-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022285-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022285-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022285-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022285-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022285-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022285-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022285-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022285-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022285-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022285-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022285-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022285-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022285-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022285-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022285-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022285-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022285-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022285-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022285-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022285-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022285-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022285-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022285-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022285-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022285-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022285-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022285-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022285-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022285-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022285-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022285-002	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022285-002	7858122	2028-09-17	Drug product		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022285-002	7858122	2028-09-17	Drug product		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022285-002	7858122	2028-09-17	Drug product		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022285-002	7858122	2028-09-17	Drug product		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022285-002	7858122	2028-09-17	Drug product		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022285-002	7858122	2028-09-17	Drug product		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022285-002	7858122	2028-09-17	Drug product		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022285-002	7858122	2028-09-17	Drug product		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022285-002	7858122	2028-09-17	Drug product		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022285-002	7858122	2028-09-17	Drug product		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022285-002	7858122	2028-09-17	Drug product		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022285-002	7858122	2028-09-17	Drug product		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022285-002	7858122	2028-09-17	Drug product		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022285-002	7858122	2028-09-17	Drug product		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022285-002	7858122	2028-09-17	Drug product		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022285-002	7858122	2028-09-17	Drug product		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022285-002	7858122	2028-09-17	Drug product		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022285-002	7858122	2028-09-17	Drug product		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022285-002	7858122	2028-09-17	Drug product		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022285-002	7858122	2028-09-17	Drug product		`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65084-461-20	2020-07-22	C162847	48780-1	ab0e2407-35e7-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use KEPPRA XR ® safely and effectively. See full prescribing information for KEPPRA XR. KEPPRA XR (levetiracetam) extended-release tablets, for oral use Initial U.S. Approval: 1999

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
levetiracetam	ACTIVE INGREDIENT	44YRR34555	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [RXPAK DIVISION OF MCKESSON CORPORATION]	1
levetiracetam	ACTIVE MOIETY	44YRR34555	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [RXPAK DIVISION OF MCKESSON CORPORATION]	1
alcohol	INACTIVE INGREDIENT	3K9958V90M	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [RXPAK DIVISION OF MCKESSON CORPORATION]	1
butyl alcohol	INACTIVE INGREDIENT	8PJ61P6TS3	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [RXPAK DIVISION OF MCKESSON CORPORATION]	1
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [RXPAK DIVISION OF MCKESSON CORPORATION]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [RXPAK DIVISION OF MCKESSON CORPORATION]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [RXPAK DIVISION OF MCKESSON CORPORATION]	1
methyl alcohol	INACTIVE INGREDIENT	Y4S76JWI15	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [RXPAK DIVISION OF MCKESSON CORPORATION]	1
Polyethylene Glycol 3350	INACTIVE INGREDIENT	G2M7P15E5P	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [RXPAK DIVISION OF MCKESSON CORPORATION]	1
polyethylene glycol 6000	INACTIVE INGREDIENT	30IQX730WE	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [RXPAK DIVISION OF MCKESSON CORPORATION]	1
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [RXPAK DIVISION OF MCKESSON CORPORATION]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [RXPAK DIVISION OF MCKESSON CORPORATION]	1
shellac	INACTIVE INGREDIENT	46N107B71O	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [RXPAK DIVISION OF MCKESSON CORPORATION]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [RXPAK DIVISION OF MCKESSON CORPORATION]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [RXPAK DIVISION OF MCKESSON CORPORATION]	1

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
Keppra XR	LEVETIRACETAM	UCB, Inc.	2919e43b-69a8-434c-a2d2-1f3ecd7554c0	2025-06-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022285 application number: NDA022285