Levetiracetam

Product NDC: 50228-189
11-digit product format: 502280189
Labeler code: 50228
Product ID: 50228-189_1d0dd4a0-35e6-418b-e063-6394a90a8b2b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levetiracetam
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: ScieGen Pharmaceuticals, Inc
Application: ANDA205130
Marketing category: ANDA
Marketing start: 2020-11-27
Substance: LEVETIRACETAM
Active strength: 500 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205130-001	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2020-11-27
A205130-002	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2020-11-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A205130-001	AB
A205130-002	AB

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 · 74 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
2026-08-18 06:07:40	2026-07	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205130-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205130-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205130-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205130-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205130-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205130-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205130-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205130-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205130-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205130-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205130-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205130-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205130-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205130-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205130-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205130-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205130-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205130-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205130-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205130-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205130-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205130-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205130-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205130-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205130-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205130-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205130-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205130-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205130-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205130-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205130-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205130-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205130-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205130-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205130-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205130-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A205130-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205130-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205130-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205130-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Levetiracetam
Brand name suffix: Extended-Release
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVETIRACETAM	500 mg/1

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
807832	Internal RxNorm lookup
846378	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
3e32f341-9926-47a3-a942-d8b9bfa7a55b	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
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	SPL version
50228-189-05	LevetiracetamExtended-Release	500 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	500	4
50228-189-30	LevetiracetamExtended-Release	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	4
50228-189-60	LevetiracetamExtended-Release	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50228-189-60	EA - Each	50228-189	4a4cbfce-c71b-402c-a3bb-0757499cceb7	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50228-189	LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [SCIEGEN PHARMACEUTICALS, INC]	4	Current NDC, Legacy NDC, 3 package rows	20240713_3e32f341-9926-47a3-a942-d8b9bfa7a55b.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam ER	LEVETIRACETAM	REMEDYREPACK INC.	2d57f22f-fecc-466e-a444-87708c7c2f80	2025-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205130 application number: ANDA205130
Levetiracetam Extended-Release	LEVETIRACETAM	ScieGen Pharmaceuticals, Inc	3e32f341-9926-47a3-a942-d8b9bfa7a55b	2024-07-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205130 application number: ANDA205130 ndc (product): 50228-189
Levetiracetam ER	LEVETIRACETAM	Westminster Pharmaceuticals, LLC	c508a392-0603-477d-8a45-3ec550371111	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205130 application number: ANDA205130
Levetiracetam ER	LEVETIRACETAM	Proficient Rx LP	a0ad8200-70c9-4f4f-86c5-4a8c6c9f0223	2022-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205130 application number: ANDA205130
Levetiracetam ER	LEVETIRACETAM	Proficient Rx LP	57b9dccb-6ee6-4e89-ab26-4c478e2df2b5	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205130 application number: ANDA205130

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
807832	levETIRAcetam 500 MG 24HR Extended Release Oral Tablet	PSN	3e32f341-9926-47a3-a942-d8b9bfa7a55b	4
846378	levETIRAcetam 750 MG 24HR Extended Release Oral Tablet	PSN	3e32f341-9926-47a3-a942-d8b9bfa7a55b	4
807832	24 HR levetiracetam 500 MG Extended Release Oral Tablet	SCD	3e32f341-9926-47a3-a942-d8b9bfa7a55b	4
846378	24 HR levetiracetam 750 MG Extended Release Oral Tablet	SCD	3e32f341-9926-47a3-a942-d8b9bfa7a55b	4
807832	levetiracetam 500 MG 24 HR Extended Release Oral Tablet	SY	3e32f341-9926-47a3-a942-d8b9bfa7a55b	4
846378	levetiracetam 750 MG 24 HR Extended Release Oral Tablet	SY	3e32f341-9926-47a3-a942-d8b9bfa7a55b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50228-189-05	50228018905	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-189-05)	2020-11-27	0000-00-00	No	No	Current
50228-189-30	50228018930	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-189-30)	2020-11-27	0000-00-00	No	No	Current
50228-189-60	50228018960	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-189-60)	2020-11-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levetiracetam Extended-Release	ScieGen Pharmaceuticals, Inc	2024-07-12	HUMAN PRESCRIPTION DRUG LABEL	4