LEVETIRACETAM

Product NDC: 72162-2667
Requested package NDC: 72162-2667-2
11-digit product format: 721622667
Labeler code: 72162
Product ID: 72162-2667_34a4d67f-921d-43e6-ab4b-cfe3dda6bdf3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LEVETIRACETAM
Dosage form: SOLUTION
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA090079
Marketing category: ANDA
Marketing start: 2025-02-01
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
A090079-001	LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA		2012-04-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090079-001	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	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090079-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2012-04-11	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090079-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090079-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090079-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090079-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090079-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090079-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090079-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090079-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090079-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090079-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090079-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090079-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090079-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090079-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090079-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090079-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090079-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090079-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090079-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090079-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090079-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090079-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090079-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090079-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090079-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090079-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090079-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090079-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090079-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090079-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090079-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090079-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090079-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090079-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090079-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090079-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090079-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090079-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090079-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090079-001	AA	1	`f41ea6bd6efb…`

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
bb6e1c75-66eb-4d18-af70-9b51fb67c4d6	Available on FDA.report

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	Bryant Ranch Prepack	bb6e1c75-66eb-4d18-af70-9b51fb67c4d6	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090079 application number: ANDA090079 ndc (package): 72162-2667-2 ndc (product): 72162-2667 ndc11 (package): 72162266702
LEVETIRACETAM	LEVETIRACETAM	QUAGEN PHARMACEUTICALS LLC	1d67cb3c-1173-4dce-a79b-a3c36934ab2e	2025-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090079 application number: ANDA090079

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
44YRR34555	LEVETIRACETAM	102767-28-2	LEVETIRACETAM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-2667-2	72162266702	473 mL in 1 BOTTLE (72162-2667-2)	473 ml	2026-06-24	No	No	Current