LEVETIRACETAM

Product NDC: 13668-272
Requested package NDC: 13668-272-12
11-digit product format: 136680272
Labeler code: 13668
Product ID: 13668-272_724c2e0f-2d55-4a25-a514-125371becd21
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LEVETIRACETAM
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA091338
Marketing category: ANDA
Marketing start: 2026-01-30
Substance: LEVETIRACETAM
Active strength: 500 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A091338-001	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2012-05-29
A091338-002	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2012-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091338-001	AB
A091338-002	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 3 · 82 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	A091338-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091338-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091338-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091338-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091338-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091338-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091338-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091338-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091338-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091338-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091338-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091338-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091338-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091338-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091338-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091338-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091338-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091338-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091338-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091338-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091338-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091338-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091338-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091338-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091338-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091338-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091338-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091338-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091338-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091338-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091338-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091338-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091338-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091338-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091338-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091338-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091338-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091338-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091338-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091338-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2012-05-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091338-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091338-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091338-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091338-002	AB	1	`31067a03dcf5…`
2019-12-13 00:20 UTC	2019-12	A091338-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091338-002	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A091338-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091338-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091338-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091338-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091338-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091338-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091338-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091338-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091338-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091338-002	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A091338-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A091338-002	AB	1	`a50c72e98297…`

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/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
7cb669d7-d1aa-43b3-a322-0a2eaa13c656	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
13668-272-05	LEVETIRACETAM	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	16
13668-272-10	LEVETIRACETAM	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	16
13668-272-12	LEVETIRACETAM	120 in 1 BOTTLE	TABLET, EXTENDED RELEASE	120	16
13668-272-25	LEVETIRACETAM	250 in 1 BOTTLE	TABLET, EXTENDED RELEASE	250	16
13668-272-60	LEVETIRACETAM	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-272-60	EA - Each	13668-272	ab1d739b-f6c3-4a6f-a077-6eba3ebdeda1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVETIRACETAM	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	6
LEVETIRACETAM	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVETIRACETAM TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	6
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVETIRACETAM TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	6
COPOVIDONE	INACTIVE INGREDIENT	D9C330MD8B	LEVETIRACETAM TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LEVETIRACETAM TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVETIRACETAM TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	6
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LEVETIRACETAM TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVETIRACETAM TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	6

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEVETIRACETAM	LEVETIRACETAM	Torrent Pharmaceuticals Limited	7cb669d7-d1aa-43b3-a322-0a2eaa13c656	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091338 application number: ANDA091338 ndc (package): 13668-272-12 ndc (product): 13668-272 ndc11 (package): 13668027212

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	7cb669d7-d1aa-43b3-a322-0a2eaa13c656	16
846378	levETIRAcetam 750 MG 24HR Extended Release Oral Tablet	PSN	7cb669d7-d1aa-43b3-a322-0a2eaa13c656	16
807832	24 HR levetiracetam 500 MG Extended Release Oral Tablet	SCD	7cb669d7-d1aa-43b3-a322-0a2eaa13c656	16
846378	24 HR levetiracetam 750 MG Extended Release Oral Tablet	SCD	7cb669d7-d1aa-43b3-a322-0a2eaa13c656	16
807832	levetiracetam 500 MG 24 HR Extended Release Oral Tablet	SY	7cb669d7-d1aa-43b3-a322-0a2eaa13c656	16
846378	levetiracetam 750 MG 24 HR Extended Release Oral Tablet	SY	7cb669d7-d1aa-43b3-a322-0a2eaa13c656	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
13668-272-12	13668027212	120 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-272-12)	2026-01-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LEVETIRACETAM	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc.	2026-04-02	HUMAN PRESCRIPTION DRUG LABEL	16