Levetiracetam

Product NDC: 63739-158
11-digit product format: 637390158
Labeler code: 63739
Product ID: 63739-158_cfa2687a-92d1-4da7-ae11-c1e322bd8176
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: SOLUTION
Route: ORAL
Labeler: McKesson Corporation dba SKY Packaging
Application: ANDA201157
Marketing category: ANDA
Marketing start: 2022-07-01
Marketing end: 2026-06-30
Substance: LEVETIRACETAM
Active strength: 100 mg/mL
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63739-158		D	Discontinued by firm	2026-08-17
excluded package	package	63739-158	63739-158-32	D	Discontinued by firm	2026-08-17
excluded package	package	63739-158	63739-158-78	D	Discontinued by firm	2026-08-17

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
A201157-001	LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA		2015-06-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201157-001	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	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`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	A201157-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201157-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201157-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201157-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201157-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201157-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201157-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201157-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201157-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201157-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201157-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201157-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201157-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201157-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201157-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201157-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201157-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201157-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201157-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201157-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201157-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201157-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201157-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201157-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201157-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201157-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201157-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201157-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201157-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201157-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201157-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201157-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201157-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201157-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201157-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201157-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201157-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201157-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201157-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201157-001	AA	1	`e64feba35796…`

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
63739-158-32	Levetiracetam	10 in 1 TRAY	SOLUTION	10	8
63739-158-32	Levetiracetam	4 in 1 CASE	SOLUTION	4	8
63739-158-70	Levetiracetam	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	8
63739-158-78	Levetiracetam	3 in 1 CASE	SOLUTION	3	8
63739-158-78	Levetiracetam	10 in 1 TRAY	SOLUTION	10	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63739-158-32	ML - Milliliter	63739-158	81ba70d7-503f-46a3-b2b0-0f1361f5cfa2	1	2022-08-04
63739-158-70	ML - Milliliter	63739-158	79d0de9b-28bb-46fe-b894-64f114f0f66b	1	2022-08-04
63739-158-78	ML - Milliliter	63739-158	34032009-bf2b-4831-9d4f-245d23ef7ac1	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63739-158	LEVETIRACETAM SOLUTION [MCKESSON CORPORATION DBA SKY PACKAGING]	8	Current NDC, Legacy NDC, 5 package rows	20250308_7a0d7f05-e091-4d9b-93f5-fd2c7f728a83.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	Cardinal Health 107, LLC	a91defd2-486b-4995-ba4c-640525ab575d	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201157 application number: ANDA201157
Levetiracetam	LEVETIRACETAM	Cardinal Health 107, LLC	f924d55d-d7ec-4448-b54e-3a7eaf5a1cab	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201157 application number: ANDA201157
Levetiracetam	LEVETIRACETAM	Major Pharmaceuticals	423d2185-0931-4414-8864-7594000809ee	2024-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201157 application number: ANDA201157
Levetiracetam	LEVETIRACETAM	PAI Holdings, LLC dba PAI Pharma	9dca1330-52ca-47a4-a134-ec55c9d5786d	2024-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201157 application number: ANDA201157

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	7a0d7f05-e091-4d9b-93f5-fd2c7f728a83	8
403884	levetiracetam 100 MG/ML Oral Solution	SCD	7a0d7f05-e091-4d9b-93f5-fd2c7f728a83	8
403884	levetiracetam 100 MG per 1 ML Oral Solution	SY	7a0d7f05-e091-4d9b-93f5-fd2c7f728a83	8
403884	levetiracetam 1000 MG per 10 ML Oral Solution	SY	7a0d7f05-e091-4d9b-93f5-fd2c7f728a83	8
403884	levetiracetam 1500 MG per 15 ML Oral Solution	SY	7a0d7f05-e091-4d9b-93f5-fd2c7f728a83	8
403884	levetiracetam 500 MG per 5 ML Oral Solution	SY	7a0d7f05-e091-4d9b-93f5-fd2c7f728a83	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63739-158-32	63739015832	4 TRAY in 1 CASE (63739-158-32) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (63739-158-70)	4 tray	2022-07-01	2026-06-30	No	No	Current
63739-158-70	63739015870	5 mL in 1 CUP, UNIT-DOSE	5 ml					Historical
63739-158-78	63739015878	3 TRAY in 1 CASE (63739-158-78) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (63739-158-70)	3 tray	2023-05-01	2026-06-30	No	No	Historical