Keppra

Product NDC: 50474-598
11-digit product format: 504740598
Labeler code: 50474
Product ID: 50474-598_38534148-3717-03b3-e063-6394a90a0f1e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levetiracetam
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: UCB, Inc.
Application: NDA022285
Marketing category: NDA
Marketing start: 2008-09-24
Substance: LEVETIRACETAM
Active strength: 500 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Keppra
Brand name suffix: XR
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVETIRACETAM	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
44YRR34555	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
807832	Internal RxNorm lookup
807834	Internal RxNorm lookup
846378	Internal RxNorm lookup
847673	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2919e43b-69a8-434c-a2d2-1f3ecd7554c0	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50474-598-66	Keppra XR	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	60		31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50474-598-66	EA - Each	50474-598	b0bd808b-752f-48b6-8177-18cf1978b1d0	1	2012-07-24

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 [UCB, INC.]	14
levetiracetam	ACTIVE MOIETY	44YRR34555	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.]	14
alcohol	INACTIVE INGREDIENT	3K9958V90M	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.]	14
butyl alcohol	INACTIVE INGREDIENT	8PJ61P6TS3	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.]	14
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.]	14
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.]	14
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.]	14
methyl alcohol	INACTIVE INGREDIENT	Y4S76JWI15	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.]	14
Polyethylene Glycol 3350	INACTIVE INGREDIENT	G2M7P15E5P	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.]	14
polyethylene glycol 6000	INACTIVE INGREDIENT	30IQX730WE	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.]	14
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.]	14
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.]	14
shellac	INACTIVE INGREDIENT	46N107B71O	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.]	14
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.]	14
talc	INACTIVE INGREDIENT	7SEV7J4R1U	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.]	14
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50474-598	KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.]	30	Current NDC, Legacy NDC, 1 package rows	20240430_2919e43b-69a8-434c-a2d2-1f3ecd7554c0.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
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 ndc (product): 50474-598

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
807834	KEPPRA XR 500 MG 24HR Extended Release Oral Tablet, Once-Daily	PSN	2919e43b-69a8-434c-a2d2-1f3ecd7554c0	31
847673	KEPPRA XR 750 MG 24HR Extended Release Oral Tablet, Once-Daily	PSN	2919e43b-69a8-434c-a2d2-1f3ecd7554c0	31
807832	levETIRAcetam 500 MG 24HR Extended Release Oral Tablet	PSN	2919e43b-69a8-434c-a2d2-1f3ecd7554c0	31
846378	levETIRAcetam 750 MG 24HR Extended Release Oral Tablet	PSN	2919e43b-69a8-434c-a2d2-1f3ecd7554c0	31
807834	24 HR levetiracetam 500 MG Extended Release Oral Tablet [Keppra]	SBD	2919e43b-69a8-434c-a2d2-1f3ecd7554c0	31
847673	24 HR levetiracetam 750 MG Extended Release Oral Tablet [Keppra]	SBD	2919e43b-69a8-434c-a2d2-1f3ecd7554c0	31
807832	24 HR levetiracetam 500 MG Extended Release Oral Tablet	SCD	2919e43b-69a8-434c-a2d2-1f3ecd7554c0	31
846378	24 HR levetiracetam 750 MG Extended Release Oral Tablet	SCD	2919e43b-69a8-434c-a2d2-1f3ecd7554c0	31
807834	24 HR Keppra 500 MG Extended Release Oral Tablet	SY	2919e43b-69a8-434c-a2d2-1f3ecd7554c0	31
847673	24 HR Keppra 750 MG Extended Release Oral Tablet	SY	2919e43b-69a8-434c-a2d2-1f3ecd7554c0	31
847673	24 HR Keppra XR 750 MG Extended Release Oral Tablet	SY	2919e43b-69a8-434c-a2d2-1f3ecd7554c0	31
807834	Keppra XR 500 MG 24 HR Extended Release Oral Tablet	SY	2919e43b-69a8-434c-a2d2-1f3ecd7554c0	31
847673	Keppra XR 750 MG 24 HR Extended Release Oral Tablet	SY	2919e43b-69a8-434c-a2d2-1f3ecd7554c0	31
807832	levetiracetam 500 MG 24 HR Extended Release Oral Tablet	SY	2919e43b-69a8-434c-a2d2-1f3ecd7554c0	31
846378	levetiracetam 750 MG 24 HR Extended Release Oral Tablet	SY	2919e43b-69a8-434c-a2d2-1f3ecd7554c0	31

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50474-598-66	50474059866	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50474-598-66)	2008-09-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Keppra XR	UCB, Inc.	2025-06-24	HUMAN PRESCRIPTION DRUG LABEL	31
Keppra XR	REMEDYREPACK INC.	2024-06-19	HUMAN PRESCRIPTION DRUG LABEL	8
Keppra XR	Mckesson Rxpak Inc	2017-06-14	HUMAN PRESCRIPTION DRUG LABEL	7