LEVETIRACETAM

Product NDC: 58657-860
Requested package NDC: 58657-860-10
11-digit product format: 586570860
Labeler code: 58657
Product ID: 58657-860_47cfd9a6-663a-7cc6-e063-6294a90a4666
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levetiracetam
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Method Pharmaceuticals, LLC
Application: ANDA209781
Marketing category: ANDA
Marketing start: 2025-12-15
Substance: LEVETIRACETAM
Active strength: 500 mg/5mL
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
A209781-001	LEVETIRACETAM	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP		2018-03-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209781-001	AP

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	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209781-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-03-20	`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	A209781-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209781-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209781-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209781-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209781-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209781-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209781-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209781-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209781-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209781-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209781-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209781-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209781-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209781-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209781-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209781-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209781-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209781-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209781-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209781-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209781-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209781-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209781-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209781-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209781-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209781-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209781-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209781-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209781-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209781-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209781-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209781-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209781-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209781-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209781-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209781-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209781-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209781-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209781-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209781-001	AP	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	500 mg/5mL

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
647121	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
47cfe577-b4cb-d35e-e063-6394a90ad8c4	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
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
525a8d4d-1988-fc3f-e292-27fd384de4f0	Product name	8	20230104
32b651f8-caa7-6882-11c7-54c4ad21796b	Product name	8	20201216
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
ce453ca5-90cf-41ed-9de4-de519f70a0f2	Product name	2	20160303
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
66666eb8-1fa6-4a60-bae9-e564e73b4cd5	Product name	1	20150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477	Product name	1	20150410
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58657-860-00	LEVETIRACETAM	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION	5	1
58657-860-01	LEVETIRACETAM	1 in 1 CARTON	INJECTION	1	1
58657-860-10	LEVETIRACETAM	10 in 1 CARTON	INJECTION	10	1
58657-860-25	LEVETIRACETAM	25 in 1 CARTON	INJECTION	25	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58657-860-01	ML - Milliliter	58657-860	4d8c8da7-578f-4d9b-b3df-efd7434bbcc3	1	2026-02-05
58657-860-10	ML - Milliliter	58657-860	f95e9a19-34b5-492c-ae12-a28a2e683e52	1	2026-02-05
58657-860-25	ML - Milliliter	58657-860	053c495b-6451-41b1-9d52-2a52ac7c0921	1	2026-02-05

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEVETIRACETAM	LEVETIRACETAM	Method Pharmaceuticals, LLC	47cfe577-b4cb-d35e-e063-6394a90ad8c4	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209781 application number: ANDA209781 ndc (package): 58657-860-10 ndc (product): 58657-860 ndc11 (package): 58657086010
Levetiracetam	LEVETIRACETAM	TAGI Pharma, Inc.	72f7ddd9-1b2c-4e26-8060-20e10c1c5d1c	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209781 application number: ANDA209781
Levetiracetam	LEVETIRACETAM	Precision Dose, Inc.	6fb1e4d3-520c-44f1-a09d-d7b779e4edfd	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209781 application number: ANDA209781

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
647121	levETIRAcetam 500 MG in 5 ML Injection	PSN	47cfe577-b4cb-d35e-e063-6394a90ad8c4	1
647121	5 ML levetiracetam 100 MG/ML Injection	SCD	47cfe577-b4cb-d35e-e063-6394a90ad8c4	1
647121	levetiracetam 500 MG per 5 ML Injection	SY	47cfe577-b4cb-d35e-e063-6394a90ad8c4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
58657-860-10	58657086010	10 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-10) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00)	2025-12-15	No	No	Current