Levetiracetam

Product NDC: 65862-315
11-digit product format: 658620315
Labeler code: 65862
Product ID: 65862-315_61244070-03c7-41d1-a784-b46dfc93fcbc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA078993
Marketing category: ANDA
Marketing start: 2009-01-15
Substance: LEVETIRACETAM
Active strength: 1000 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

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
unfinished product	product	65862-315		UNFINISHED	Active or certified unfinished drug listing		2026-08-12
unfinished package	package	65862-315	65862-315-99	UNFINISHED	Active or certified unfinished drug listing		2026-08-12

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 · 42 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 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-315-99	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-315-99	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-315-99	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-315-99	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-315-99	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-315-99	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-315-99	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-315-99	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-315-99	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-315-99	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-315-99	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-315-99	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-315-99	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-315-99	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-315-99	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	65862-315-99	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	65862-315-99	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	65862-315-99	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	65862-315-99	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	65862-315-99	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	65862-315-99	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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
A078993-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15
A078993-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15
A078993-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15
A078993-004	LEVETIRACETAM	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078993-001	AB
A078993-002	AB
A078993-003	AB
A078993-004	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	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`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	A078993-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078993-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078993-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078993-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078993-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078993-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078993-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078993-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078993-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078993-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078993-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078993-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078993-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078993-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078993-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078993-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Levetiracetam
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVETIRACETAM	1000 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
311288	Internal RxNorm lookup
311289	Internal RxNorm lookup
311290	Internal RxNorm lookup
387003	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
2471ee03-d747-4113-86d0-1aa93c8f3eba	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
087c9486-f4a9-a565-c6fb-d6fa49f4572a	Product name	6	20230317
525a8d4d-1988-fc3f-e292-27fd384de4f0	Product name	8	20230104
32b651f8-caa7-6882-11c7-54c4ad21796b	Product name	8	20201216
ce453ca5-90cf-41ed-9de4-de519f70a0f2	Product name	2	20160303
66666eb8-1fa6-4a60-bae9-e564e73b4cd5	Product name	1	20150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477	Product name	1	20150410

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65862-315-05	Levetiracetam	500 in 1 BOTTLE	TABLET, FILM COATED	500	29
65862-315-30	Levetiracetam	30 in 1 BOTTLE	TABLET, FILM COATED	30	29
65862-315-60	Levetiracetam	60 in 1 BOTTLE	TABLET, FILM COATED	60	29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-315-60	EA - Each	65862-315	5ad2853e-cde8-4221-a4e8-5492bd4e5a7c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVETIRACETAM	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
LEVETIRACETAM	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
WATER	INACTIVE INGREDIENT	059QF0KO0R	LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-315	LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	29	Current NDC, Legacy NDC, 3 package rows	20240406_2471ee03-d747-4113-86d0-1aa93c8f3eba.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	Unit Dose Solutions, Inc.	551626eb-3282-e439-e063-6294a90a8314	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	Coupler LLC	53843871-23e3-974e-e063-6394a90a8042	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	Coupler LLC	51b66893-f7d6-8f9d-e063-6294a90a8e9b	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	Coupler LLC	5037a86a-21f2-d793-e063-6394a90a2cb5	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	6e31e766-6504-4f20-8831-1953363cace0	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	01aef7f7-6092-4e39-8451-dc02d8db9254	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	58ed7049-44c6-4f97-9174-c0e1504586a6	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	5eb7bea5-c95f-4a38-a5bb-c20d1549c797	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	bc12f0b0-e05c-48e4-ad08-0ff14a818a64	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	Major Pharmaceuticals	c4b27429-50a3-467c-a5ff-7e49a01a1088	2025-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	Cardinal Health 107, LLC	0348fec4-d919-4307-ac90-35360819bc00	2025-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	BluePoint Laboratories	8b74b8bc-d95c-4471-8f74-c3117243bf89	2024-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	American Health Packaging	fc8bf57e-8aa2-4d3c-856d-b19de65e3ba0	2024-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	American Health Packaging	031a32e1-675a-4efe-a66b-40beb4fe5101	2024-06-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	Aurobindo Pharma Limited	2471ee03-d747-4113-86d0-1aa93c8f3eba	2024-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993 ndc (product): 65862-315

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	2471ee03-d747-4113-86d0-1aa93c8f3eba	29
311288	levETIRAcetam 250 MG Oral Tablet	PSN	2471ee03-d747-4113-86d0-1aa93c8f3eba	29
311289	levETIRAcetam 500 MG Oral Tablet	PSN	2471ee03-d747-4113-86d0-1aa93c8f3eba	29
311290	levETIRAcetam 750 MG Oral Tablet	PSN	2471ee03-d747-4113-86d0-1aa93c8f3eba	29
387003	levetiracetam 1000 MG Oral Tablet	SCD	2471ee03-d747-4113-86d0-1aa93c8f3eba	29
311288	levetiracetam 250 MG Oral Tablet	SCD	2471ee03-d747-4113-86d0-1aa93c8f3eba	29
311289	levetiracetam 500 MG Oral Tablet	SCD	2471ee03-d747-4113-86d0-1aa93c8f3eba	29
311290	levetiracetam 750 MG Oral Tablet	SCD	2471ee03-d747-4113-86d0-1aa93c8f3eba	29
387003	levETIRAcetam 1000 MG Oral Tablet	PSN	48fc5196-2875-1c57-e054-00144ff8d46c	2
387003	levetiracetam 1000 MG Oral Tablet	SCD	48fc5196-2875-1c57-e054-00144ff8d46c	2
387003	levETIRAcetam 1000 MG Oral Tablet	PSN	58ed7049-44c6-4f97-9174-c0e1504586a6	1
387003	levETIRAcetam 1000 MG Oral Tablet	PSN	8a719215-d0d4-42fb-e053-2a95a90a60da	1
387003	levETIRAcetam 1000 MG Oral Tablet	PSN	bc12f0b0-e05c-48e4-ad08-0ff14a818a64	1
387003	levetiracetam 1000 MG Oral Tablet	SCD	58ed7049-44c6-4f97-9174-c0e1504586a6	1
387003	levetiracetam 1000 MG Oral Tablet	SCD	8a719215-d0d4-42fb-e053-2a95a90a60da	1
387003	levetiracetam 1000 MG Oral Tablet	SCD	bc12f0b0-e05c-48e4-ad08-0ff14a818a64	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-315-05	65862031505	500 TABLET, FILM COATED in 1 BOTTLE (65862-315-05)	2009-01-15	0000-00-00	No	No	Current
65862-315-30	65862031530	30 TABLET, FILM COATED in 1 BOTTLE (65862-315-30)	2009-01-15	0000-00-00	No	No	Current
65862-315-60	65862031560	60 TABLET, FILM COATED in 1 BOTTLE (65862-315-60)	2009-01-15	0000-00-00	No	No	Current
65862-315-99	65862031599	1000 TABLET, FILM COATED in 1 BAG (65862-315-99)	15-JAN-09				Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levetiracetam	A-S Medication Solutions	2025-11-19	Human Prescription Drug Label	1
Levetiracetam	A-S Medication Solutions	2025-11-19	Human Prescription Drug Label	1
Levetiracetam	REMEDYREPACK INC.	2025-06-27	HUMAN PRESCRIPTION DRUG LABEL	8
Levetiracetam	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2024-04-04	Human Prescription Drug Label	29
LEVETIRACETAM	DIRECT RX	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	2
LEVERTIRACETAM	Direct_Rx	2019-06-03	HUMAN PRESCRIPTION DRUG LABEL	1