Levetiracetam

Product NDC: 81646-116
Requested package NDC: 81646-116-05
11-digit product format: 816460116
Labeler code: 81646
Product ID: 81646-116_a279dd0a-b4f9-4b28-8d1c-1c4d58fefa7c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LEVETIRACETAM
Dosage form: SOLUTION
Route: ORAL
Labeler: PINNACLE PHARMA LLC
Application: ANDA201157
Marketing category: ANDA
Marketing start: 2015-06-04
Marketing end: 0000-00-00
Substance: LEVETIRACETAM
Active strength: 500 mg/5mL
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	81646-116	81646-116-05	I	Inactivated by FDA		2026-08-03

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201157-001	AA	1	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
81646-116-05	2023-01-30	C162847	48780-1	f386c649-e0ac-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use LEVETIRACETAM oral solution USP safely and effectively. See full prescribing information for Levetiracetam Oral Solution USP. Levetiracetam Oral Solution USP Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81646-116-05	Levetiracetam	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81646-116	LEVETIRACETAM SOLUTION [PINNACLE PHARMA LLC]	2	Legacy NDC, 1 package rows	20210515_3a472ddb-ecde-4d51-adbc-d95a96cf85d3.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	3a472ddb-ecde-4d51-adbc-d95a96cf85d3	2
403884	levetiracetam 100 MG/ML Oral Solution	SCD	3a472ddb-ecde-4d51-adbc-d95a96cf85d3	2
403884	levetiracetam 100 MG per 1 ML Oral Solution	SY	3a472ddb-ecde-4d51-adbc-d95a96cf85d3	2
403884	levetiracetam 1000 MG per 10 ML Oral Solution	SY	3a472ddb-ecde-4d51-adbc-d95a96cf85d3	2
403884	levetiracetam 1500 MG per 15 ML Oral Solution	SY	3a472ddb-ecde-4d51-adbc-d95a96cf85d3	2
403884	levetiracetam 500 MG per 5 ML Oral Solution	SY	3a472ddb-ecde-4d51-adbc-d95a96cf85d3	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81646-116-05	81646011605	5 mL in 1 CUP, UNIT-DOSE (81646-116-05)	5 ml	2015-06-04	0000-00-00	No	No	Current