Levetiracetam

Product NDC: 60505-3518
11-digit product format: 605053518
Labeler code: 60505
Product ID: 60505-3518_24652d3c-86ad-7b6e-6a54-d0a6f952c913
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA202958
Marketing category: ANDA
Marketing start: 2015-02-25
Substance: LEVETIRACETAM
Active strength: 1000 mg/1
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
A202958-001	LEVETIRACETAM	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL			2015-02-25

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202958-001	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL	2015-02-25	`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	1000 mg/1

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60505-3518-6	Levetiracetam	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60		20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVETIRACETAM	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]	7
LEVETIRACETAM	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]	7
Hydroxypropyl Cellulose (Type H)	INACTIVE INGREDIENT	RFW2ET671P	LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]	7
HYPROMELLOSE 2208 (15000 MPA.S)	INACTIVE INGREDIENT	Z78RG6M2N2	LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]	7
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]	7
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-3518	LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]	19	Current NDC, Legacy NDC, 1 package rows	20241012_abc9fada-c5c2-4e07-fb8a-4d1518f7657e.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
1605362	levETIRAcetam 1000 MG 24HR Extended Release Oral Tablet	PSN	abc9fada-c5c2-4e07-fb8a-4d1518f7657e	20
807832	levETIRAcetam 500 MG 24HR Extended Release Oral Tablet	PSN	abc9fada-c5c2-4e07-fb8a-4d1518f7657e	20
846378	levETIRAcetam 750 MG 24HR Extended Release Oral Tablet	PSN	abc9fada-c5c2-4e07-fb8a-4d1518f7657e	20
1605362	24 HR levetiracetam 1000 MG Extended Release Oral Tablet	SCD	abc9fada-c5c2-4e07-fb8a-4d1518f7657e	20
807832	24 HR levetiracetam 500 MG Extended Release Oral Tablet	SCD	abc9fada-c5c2-4e07-fb8a-4d1518f7657e	20
846378	24 HR levetiracetam 750 MG Extended Release Oral Tablet	SCD	abc9fada-c5c2-4e07-fb8a-4d1518f7657e	20
1605362	levetiracetam 1000 MG 24 HR Extended Release Oral Tablet	SY	abc9fada-c5c2-4e07-fb8a-4d1518f7657e	20
807832	levetiracetam 500 MG 24 HR Extended Release Oral Tablet	SY	abc9fada-c5c2-4e07-fb8a-4d1518f7657e	20
846378	levetiracetam 750 MG 24 HR Extended Release Oral Tablet	SY	abc9fada-c5c2-4e07-fb8a-4d1518f7657e	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-3518-6	60505351806	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-3518-6)	2015-02-25	0000-00-00	No	No	Current