Keppra

Product NDC: 21695-070
11-digit product format: 216950070
Labeler code: 21695
Product ID: 21695-070_d1329893-a8bc-4f31-a31b-76690d111035
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levetiracetam
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA021035
Marketing category: NDA
Marketing start: 2000-04-24
Marketing end: 0000-00-00
Substance: LEVETIRACETAM
Active strength: 500 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-070		I	Inactivated by FDA		2026-08-07
excluded package	package	21695-070	21695-070-15	I	Inactivated by FDA		2026-08-07

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 · 44 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	21695-070-15	`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	21695-070-15	`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	21695-070-15	`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	21695-070-15	`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	21695-070-15	`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	21695-070-15	`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	21695-070-15	`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	21695-070-15	`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	21695-070-15	`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	21695-070-15	`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	21695-070-15	`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	21695-070-15	`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	21695-070-15	`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	21695-070-15	`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	21695-070-15	`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	21695-070-15	`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	21695-070-15	`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	21695-070-15	`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	21695-070-15	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-070-15	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-070-15	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-070-15	`110d247fa046…`	`a55b01930146…`

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	RLD / RS	Approval date
N021035-001	KEPPRA	LEVETIRACETAM	250MG	TABLET / ORAL	AB	RLD	1999-11-30
N021035-002	KEPPRA	LEVETIRACETAM	500MG	TABLET / ORAL	AB	RLD	1999-11-30
N021035-003	KEPPRA	LEVETIRACETAM	750MG	TABLET / ORAL	AB	RLD	1999-11-30
N021035-004	KEPPRA	LEVETIRACETAM	1GM	TABLET / ORAL	AB	RLD, RS	2006-01-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021035-001	AB
N021035-002	AB
N021035-003	AB
N021035-004	AB

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N021035-001	8802142	2031-06-07	Drug product	2014-09-10
N021035-001	8802142*PED	2031-12-07	Pediatric extension
N021035-002	8802142	2031-06-07	Drug product	2014-09-10
N021035-002	8802142*PED	2031-12-07	Pediatric extension
N021035-003	8802142	2031-06-07	Drug product	2014-09-10
N021035-003	8802142*PED	2031-12-07	Pediatric extension
N021035-004	8802142	2031-06-07	Drug product	2014-09-10
N021035-004	8802142*PED	2031-12-07	Pediatric extension

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021035-001	KEPPRA	250MG	TABLET / ORAL	AB	RLD	1999-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021035-002	KEPPRA	500MG	TABLET / ORAL	AB	RLD	1999-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021035-003	KEPPRA	750MG	TABLET / ORAL	AB	RLD	1999-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021035-004	KEPPRA	1GM	TABLET / ORAL	AB	RLD, RS	2006-01-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021035-001	KEPPRA	250MG	TABLET / ORAL	AB	RLD	1999-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021035-002	KEPPRA	500MG	TABLET / ORAL	AB	RLD	1999-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021035-003	KEPPRA	750MG	TABLET / ORAL	AB	RLD	1999-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021035-004	KEPPRA	1GM	TABLET / ORAL	AB	RLD, RS	2006-01-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021035-001	KEPPRA	250MG	TABLET / ORAL	AB	RLD	1999-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021035-002	KEPPRA	500MG	TABLET / ORAL	AB	RLD	1999-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021035-003	KEPPRA	750MG	TABLET / ORAL	AB	RLD	1999-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021035-004	KEPPRA	1GM	TABLET / ORAL	AB	RLD, RS	2006-01-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021035-001	KEPPRA	250MG	TABLET / ORAL	AB	RLD	1999-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021035-002	KEPPRA	500MG	TABLET / ORAL	AB	RLD	1999-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021035-003	KEPPRA	750MG	TABLET / ORAL	AB	RLD	1999-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021035-004	KEPPRA	1GM	TABLET / ORAL	AB	RLD, RS	2006-01-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021035-001	KEPPRA	250MG	TABLET / ORAL	AB	RLD	1999-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021035-002	KEPPRA	500MG	TABLET / ORAL	AB	RLD	1999-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021035-003	KEPPRA	750MG	TABLET / ORAL	AB	RLD	1999-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021035-004	KEPPRA	1GM	TABLET / ORAL	AB	RLD, RS	2006-01-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021035-001	KEPPRA	250MG	TABLET / ORAL	AB	RLD	1999-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021035-002	KEPPRA	500MG	TABLET / ORAL	AB	RLD	1999-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021035-003	KEPPRA	750MG	TABLET / ORAL	AB	RLD	1999-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021035-004	KEPPRA	1GM	TABLET / ORAL	AB	RLD, RS	2006-01-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021035-001	KEPPRA	250MG	TABLET / ORAL	AB	RLD	1999-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021035-002	KEPPRA	500MG	TABLET / ORAL	AB	RLD	1999-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021035-003	KEPPRA	750MG	TABLET / ORAL	AB	RLD	1999-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021035-004	KEPPRA	1GM	TABLET / ORAL	AB	RLD, RS	2006-01-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021035-001	KEPPRA	250MG	TABLET / ORAL	AB	RLD	1999-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021035-002	KEPPRA	500MG	TABLET / ORAL	AB	RLD	1999-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021035-003	KEPPRA	750MG	TABLET / ORAL	AB	RLD	1999-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021035-004	KEPPRA	1GM	TABLET / ORAL	AB	RLD, RS	2006-01-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021035-001	KEPPRA	250MG	TABLET / ORAL	AB	RLD	1999-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021035-002	KEPPRA	500MG	TABLET / ORAL	AB	RLD	1999-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021035-003	KEPPRA	750MG	TABLET / ORAL	AB	RLD	1999-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021035-004	KEPPRA	1GM	TABLET / ORAL	AB	RLD, RS	2006-01-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021035-001	KEPPRA	250MG	TABLET / ORAL	AB	RLD	1999-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021035-002	KEPPRA	500MG	TABLET / ORAL	AB	RLD	1999-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021035-003	KEPPRA	750MG	TABLET / ORAL	AB	RLD	1999-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021035-004	KEPPRA	1GM	TABLET / ORAL	AB	RLD, RS	2006-01-06	`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	N021035-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021035-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021035-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021035-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021035-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021035-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021035-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021035-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021035-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021035-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021035-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021035-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021035-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021035-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021035-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021035-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021035-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021035-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021035-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021035-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021035-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021035-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021035-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021035-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021035-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021035-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021035-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021035-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021035-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021035-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021035-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021035-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021035-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021035-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021035-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021035-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021035-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021035-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021035-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021035-004	AB	1	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 328 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	N021035-001	8802142	2031-06-07	Drug product	2014-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021035-001	8802142*PED	2031-12-07	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021035-002	8802142	2031-06-07	Drug product	2014-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021035-002	8802142*PED	2031-12-07	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021035-003	8802142	2031-06-07	Drug product	2014-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021035-003	8802142*PED	2031-12-07	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021035-004	8802142	2031-06-07	Drug product	2014-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021035-004	8802142*PED	2031-12-07	Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021035-001	8802142	2031-06-07	Drug product	2014-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021035-001	8802142*PED	2031-12-07	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021035-002	8802142	2031-06-07	Drug product	2014-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021035-002	8802142*PED	2031-12-07	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021035-003	8802142	2031-06-07	Drug product	2014-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021035-003	8802142*PED	2031-12-07	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021035-004	8802142	2031-06-07	Drug product	2014-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021035-004	8802142*PED	2031-12-07	Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021035-001	8802142	2031-06-07	Drug product	2014-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021035-001	8802142*PED	2031-12-07	Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021035-002	8802142	2031-06-07	Drug product	2014-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021035-002	8802142*PED	2031-12-07	Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021035-003	8802142	2031-06-07	Drug product	2014-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021035-003	8802142*PED	2031-12-07	Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021035-004	8802142	2031-06-07	Drug product	2014-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021035-004	8802142*PED	2031-12-07	Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021035-001	8802142	2031-06-07	Drug product	2014-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021035-001	8802142*PED	2031-12-07	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021035-002	8802142	2031-06-07	Drug product	2014-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021035-002	8802142*PED	2031-12-07	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021035-003	8802142	2031-06-07	Drug product	2014-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021035-003	8802142*PED	2031-12-07	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021035-004	8802142	2031-06-07	Drug product	2014-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021035-004	8802142*PED	2031-12-07	Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021035-001	8802142	2031-06-07	Drug product	2014-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021035-001	8802142*PED	2031-12-07	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021035-002	8802142	2031-06-07	Drug product	2014-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021035-002	8802142*PED	2031-12-07	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021035-003	8802142	2031-06-07	Drug product	2014-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021035-003	8802142*PED	2031-12-07	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021035-004	8802142	2031-06-07	Drug product	2014-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021035-004	8802142*PED	2031-12-07	Pediatric extension		`b8a1b40f171c…`

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
21695-070-15	2019-09-24	C162847	48780-1	934fe258-4d61-48b1-e053-8cdaa90a720a	KEPPRA ® (levetiracetam) 250 mg, 500 mg, 750 mg, and 1000 mg tablets 100 mg/mL oral solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-070-15	Keppra	15 in 1 DRUM	TABLET	15		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-070-15	EA - Each	21695-070	7655d7d9-b0be-4a99-9087-2f3785d259db	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
levetiracetam	ACTIVE INGREDIENT	44YRR34555	KEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]	1
levetiracetam	ACTIVE MOIETY	44YRR34555	KEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]	1
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	KEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	KEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]	1
FD&C yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	KEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	KEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	KEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]	1
polyethylene glycol 3350	INACTIVE INGREDIENT	G2M7P15E5P	KEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]	1
polyethylene glycol 6000	INACTIVE INGREDIENT	30IQX730WE	KEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]	1
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	KEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	KEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	KEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	KEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-070	KEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110104_d1329893-a8bc-4f31-a31b-76690d111035.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	LEVETIRACETAM	UCB, Inc.	3ca9df05-a506-4ec8-a4fe-320f1219ab21	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021035 application number: NDA021035

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
261336	Keppra 500 MG Oral Tablet	PSN	d1329893-a8bc-4f31-a31b-76690d111035	1
311289	levETIRAcetam 500 MG Oral Tablet	PSN	d1329893-a8bc-4f31-a31b-76690d111035	1
261336	levetiracetam 500 MG Oral Tablet [Keppra]	SBD	d1329893-a8bc-4f31-a31b-76690d111035	1
311289	levetiracetam 500 MG Oral Tablet	SCD	d1329893-a8bc-4f31-a31b-76690d111035	1
261336	Keppra 500 MG Oral Tablet	SY	d1329893-a8bc-4f31-a31b-76690d111035	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-070-15	21695007015	15 in 1 DRUM	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
KEPPRA ® (levetiracetam) 250 mg, 500 mg, 750 mg, and 1000 mg tablets 100 mg/mL oral solution	Rebel Distributors Corp	2010-12-28	HUMAN PRESCRIPTION DRUG LABEL	1