LEVETIRACETAM

Product NDC: 69452-412
Requested package NDC: 69452-412-88
11-digit product format: 694520412
Labeler code: 69452
Product ID: 69452-412_4fae5b8b-e3f2-f9a9-e063-6294a90ab8f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LEVETIRACETAM
Dosage form: SOLUTION
Route: ORAL
Labeler: Bionpharma Inc.
Application: ANDA079120
Marketing category: ANDA
Marketing start: 2024-07-18
Substance: LEVETIRACETAM
Active strength: 100 mg/mL
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A079120-001	LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA		2009-01-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079120-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL		2009-01-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL		2009-01-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL		2009-01-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079120-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-16	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A079120-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079120-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079120-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079120-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079120-001	AA	1	`6a471c1ec25d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079120-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079120-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079120-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079120-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079120-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079120-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079120-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079120-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079120-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079120-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079120-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079120-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079120-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079120-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079120-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079120-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079120-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079120-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079120-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079120-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079120-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079120-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079120-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079120-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079120-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079120-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079120-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079120-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079120-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079120-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079120-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079120-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079120-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079120-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A079120-001	AA	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: LEVETIRACETAM
Listing expiration: 2027-12-31

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
1d75b15e-881c-a00f-e063-6394a90a4138	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
087c9486-f4a9-a565-c6fb-d6fa49f4572a	Product name	6	20230317
525a8d4d-1988-fc3f-e292-27fd384de4f0	Product name	8	20230104
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
32b651f8-caa7-6882-11c7-54c4ad21796b	Product name	8	20201216
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
ce453ca5-90cf-41ed-9de4-de519f70a0f2	Product name	2	20160303
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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	Strength	SPL version
69452-412-88	LEVETIRACETAM	473 mL in 1 BOTTLE	SOLUTION	473		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69452-412-88	ML - Milliliter	69452-412	cdbeda23-df44-4d07-afaf-d1a3d878e0d1	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-412	LEVETIRACETAM SOLUTION [BIONPHARMA INC.]	1	Current NDC, 1 package rows	20240719_1d75b15e-881c-a00f-e063-6394a90a4138.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEVETIRACETAM	LEVETIRACETAM	Bionpharma Inc.	1d75b15e-881c-a00f-e063-6394a90a4138	2026-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079120 application number: ANDA079120 ndc (package): 69452-412-88 ndc (product): 69452-412 ndc11 (package): 69452041288
LEVETIRACETAM	LEVETIRACETAM	Kesin Pharma Corporation	30a4626d-74f3-6385-e063-6394a90a2950	2025-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079120 application number: ANDA079120

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	1d75b15e-881c-a00f-e063-6394a90a4138	2
403884	levetiracetam 100 MG/ML Oral Solution	SCD	1d75b15e-881c-a00f-e063-6394a90a4138	2
403884	levetiracetam 100 MG per 1 ML Oral Solution	SY	1d75b15e-881c-a00f-e063-6394a90a4138	2
403884	levetiracetam 1000 MG per 10 ML Oral Solution	SY	1d75b15e-881c-a00f-e063-6394a90a4138	2
403884	levetiracetam 1500 MG per 15 ML Oral Solution	SY	1d75b15e-881c-a00f-e063-6394a90a4138	2
403884	levetiracetam 500 MG per 5 ML Oral Solution	SY	1d75b15e-881c-a00f-e063-6394a90a4138	2
403884	levETIRAcetam 100 MG in 1 mL Oral Solution	PSN	30a4626d-74f3-6385-e063-6394a90a2950	1
403884	levetiracetam 100 MG/ML Oral Solution	SCD	30a4626d-74f3-6385-e063-6394a90a2950	1
403884	levetiracetam 100 MG per 1 ML Oral Solution	SY	30a4626d-74f3-6385-e063-6394a90a2950	1
403884	levetiracetam 1000 MG per 10 ML Oral Solution	SY	30a4626d-74f3-6385-e063-6394a90a2950	1
403884	levetiracetam 1500 MG per 15 ML Oral Solution	SY	30a4626d-74f3-6385-e063-6394a90a2950	1
403884	levetiracetam 500 MG per 5 ML Oral Solution	SY	30a4626d-74f3-6385-e063-6394a90a2950	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69452-412-88	69452041288	473 mL in 1 BOTTLE (69452-412-88)	473 ml	2024-07-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LEVETIRACETAM	Bionpharma Inc. \| OrBion Pharmaceuticals Private Limited	2026-04-17	HUMAN PRESCRIPTION DRUG LABEL	2
LEVETIRACETAM	Kesin Pharma Corporation	2025-03-01	HUMAN PRESCRIPTION DRUG LABEL	1