Levetiracetam

Product NDC: 60687-249
11-digit product format: 606870249
Labeler code: 60687
Product ID: 60687-249_2e6d7924-161f-38d6-e063-6294a90aad38
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: SOLUTION
Route: ORAL
Labeler: American Health Packaging
Application: ANDA203052
Marketing category: ANDA
Marketing start: 2017-11-29
Substance: LEVETIRACETAM
Active strength: 100 mg/mL
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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203052-001	LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA		2013-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203052-001	AA

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 2 · 42 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
2026-08-18 06:07:40	2026-07	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203052-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2013-02-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203052-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203052-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203052-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203052-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203052-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203052-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203052-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203052-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203052-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203052-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203052-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203052-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203052-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203052-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203052-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203052-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203052-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203052-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203052-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203052-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203052-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203052-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203052-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203052-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203052-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203052-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203052-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203052-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203052-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203052-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203052-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203052-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203052-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203052-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203052-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203052-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203052-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203052-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203052-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203052-001	AA	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVETIRACETAM	100 mg/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
403884	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
3be7c30b-f35d-4dde-8bf8-24f67bd70865	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
60687-249-40	Levetiracetam	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	8
60687-249-46	Levetiracetam	10 in 1 TRAY	SOLUTION	10	8
60687-249-67	Levetiracetam	5 in 1 CASE	SOLUTION	5	8
60687-249-77	Levetiracetam	4 in 1 CASE	SOLUTION	4	8
60687-249-86	Levetiracetam	3 in 1 CASE	SOLUTION	3	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-249-40	ML - Milliliter	60687-249	630b29a2-fa9b-438b-83e0-28524bd418f6	1	2018-01-12
60687-249-46	ML - Milliliter	60687-249	fbbe3a0f-6962-4460-ad04-b34f4e0ae030	1	2018-01-12
60687-249-67	ML - Milliliter	60687-249	23317fe4-e4fe-46d7-be84-a6343acf9abc	1	2017-12-14
60687-249-77	ML - Milliliter	60687-249	dd8cc5dd-80b6-4a35-8964-35f0c5e58371	1	2019-03-12
60687-249-86	ML - Milliliter	60687-249	c35d862e-9209-4f0f-ab07-a81458015677	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-249	LEVETIRACETAM SOLUTION [AMERICAN HEALTH PACKAGING]	8	Current NDC, Legacy NDC, 5 package rows	20250221_3be7c30b-f35d-4dde-8bf8-24f67bd70865.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam Levetiracetam	LEVETIRACETAM	Atlantic Biologicals Corp.	56fed03f-38c3-4273-8fd7-522bc508bf36	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203052 application number: ANDA203052
Levetiracetam	LEVETIRACETAM	American Health Packaging	3be7c30b-f35d-4dde-8bf8-24f67bd70865	2025-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203052 application number: ANDA203052 ndc (product): 60687-249
Levetiracetam	LEVETIRACETAM ORAL	Camber Pharmaceuticals, Inc.	0bc8468f-832c-4e71-95a2-db464d4d54bc	2024-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203052 application number: ANDA203052
Levetiracetam	LEVETIRACETAM	Natco Pharma USA LLC	34af3602-0188-4d2e-904b-2e40000bb45c	2023-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203052 application number: ANDA203052

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
403884	levETIRAcetam 100 MG in 1 mL Oral Solution	PSN	3be7c30b-f35d-4dde-8bf8-24f67bd70865	8
403884	levetiracetam 100 MG/ML Oral Solution	SCD	3be7c30b-f35d-4dde-8bf8-24f67bd70865	8
403884	levetiracetam 100 MG per 1 ML Oral Solution	SY	3be7c30b-f35d-4dde-8bf8-24f67bd70865	8
403884	levetiracetam 1000 MG per 10 ML Oral Solution	SY	3be7c30b-f35d-4dde-8bf8-24f67bd70865	8
403884	levetiracetam 1500 MG per 15 ML Oral Solution	SY	3be7c30b-f35d-4dde-8bf8-24f67bd70865	8
403884	levetiracetam 500 MG per 5 ML Oral Solution	SY	3be7c30b-f35d-4dde-8bf8-24f67bd70865	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-249-40	60687024940	5 mL in 1 CUP, UNIT-DOSE	5 ml					Historical
60687-249-46	60687024946	10 in 1 TRAY						Historical
60687-249-67	60687024967	5 TRAY in 1 CASE (60687-249-67) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-249-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-249-40)	5 tray	2017-11-29	0000-00-00	No	No	Current
60687-249-77	60687024977	4 TRAY in 1 CASE (60687-249-77) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-249-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-249-40)	4 tray	2019-03-08	0000-00-00	No	No	Current
60687-249-86	60687024986	3 TRAY in 1 CASE (60687-249-86) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-249-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-249-40)	3 tray	2023-06-15		No	No	Current