Levetiracetam

Product NDC: 25021-780
11-digit product format: 250210780
Labeler code: 25021
Product ID: 25021-780_71dae9d8-f833-46d3-9b2a-c7760742f412
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Sagent Pharmaceuticals
Application: ANDA091627
Marketing category: ANDA
Marketing start: 2013-11-01
Substance: LEVETIRACETAM
Active strength: 500 mg/5mL
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	25021-780		I	Inactivated by FDA		2026-08-11
excluded package	package	25021-780	25021-780-05	I	Inactivated by FDA		2026-08-11

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
A091627-001	LEVETIRACETAM	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP		2013-06-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091627-001	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 · 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	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`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	A091627-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091627-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091627-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091627-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091627-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091627-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091627-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091627-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091627-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091627-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091627-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091627-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091627-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091627-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091627-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091627-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091627-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091627-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091627-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091627-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091627-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091627-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091627-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091627-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091627-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091627-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091627-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091627-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091627-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091627-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091627-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091627-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091627-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091627-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091627-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091627-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091627-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091627-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091627-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091627-001	AP	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
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	Strength	SPL version
25021-780-05	Levetiracetam	5 mL in 1 VIAL	INJECTION, SOLUTION, CONCENTRATE	5		18
25021-780-05	Levetiracetam	10 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	10		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25021-780-05	ML - Milliliter	25021-780	10678131-948f-483b-9abd-9d187d3d4dc0	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Levetiracetam	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS]	8
Levetiracetam	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS]	8
acetic acid	INACTIVE INGREDIENT	Q40Q9N063P	LEVETIRACETAM INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS]	8
sodium acetate	INACTIVE INGREDIENT	4550K0SC9B	LEVETIRACETAM INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS]	8
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	LEVETIRACETAM INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS]	8
water	INACTIVE INGREDIENT	059QF0KO0R	LEVETIRACETAM INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25021-780	LEVETIRACETAM INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS]	17	Current NDC, Legacy NDC, 2 package rows	20240711_f00d8f59-c333-48ad-aca3-98a49bcd228e.zip

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	f00d8f59-c333-48ad-aca3-98a49bcd228e	18
647121	5 ML levetiracetam 100 MG/ML Injection	SCD	f00d8f59-c333-48ad-aca3-98a49bcd228e	18
647121	levetiracetam 500 MG per 5 ML Injection	SY	f00d8f59-c333-48ad-aca3-98a49bcd228e	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
25021-780-05	25021078005	10 VIAL in 1 CARTON (25021-780-05) / 5 mL in 1 VIAL	10 vial	2013-11-01	0000-00-00	No	No	Current