Levetiracetam

Product NDC: 13668-016
11-digit product format: 136680016
Labeler code: 13668
Product ID: 13668-016_b8792837-f86a-4e67-b1a5-ec8ca278fe77
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: TABLET
Route: ORAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA078858
Marketing category: ANDA
Marketing start: 2009-01-15
Substance: LEVETIRACETAM
Active strength: 750 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 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078858-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15
A078858-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15
A078858-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15
A078858-004	LEVETIRACETAM	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A078858-001	AB
A078858-002	AB
A078858-003	AB
A078858-004	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 5 · 172 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	A078858-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078858-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078858-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078858-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078858-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078858-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078858-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078858-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078858-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078858-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078858-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078858-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078858-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078858-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078858-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078858-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078858-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078858-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078858-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078858-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078858-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078858-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078858-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078858-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078858-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078858-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078858-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078858-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078858-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078858-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078858-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078858-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078858-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078858-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078858-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078858-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078858-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078858-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078858-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078858-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	A078858-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078858-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078858-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078858-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078858-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078858-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078858-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078858-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078858-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078858-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078858-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078858-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078858-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078858-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078858-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078858-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078858-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078858-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078858-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078858-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078858-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078858-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078858-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078858-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078858-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078858-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078858-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078858-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078858-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078858-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078858-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078858-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078858-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078858-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078858-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078858-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078858-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078858-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078858-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078858-004	AB	1	`5bbf6a4d5a75…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVETIRACETAM	750 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311288	Internal RxNorm lookup
311289	Internal RxNorm lookup
311290	Internal RxNorm lookup
387003	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
6ab24168-058d-496e-9023-da8ee6353eb3	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
13668-016-05	Levetiracetam	500 in 1 BOTTLE	TABLET	500	27
13668-016-12	Levetiracetam	120 in 1 BOTTLE	TABLET	120	27
13668-016-25	Levetiracetam	250 in 1 BOTTLE	TABLET	250	27
13668-016-60	Levetiracetam	60 in 1 BOTTLE	TABLET	60	27
13668-016-67	Levetiracetam	800 in 1 BOTTLE	TABLET	800	27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-016-05	EA - Each	13668-016	c928800a-2d6e-44e9-9572-32bab3d0f73d	1	2012-07-24
13668-016-12	EA - Each	13668-016	d2274d5c-f21c-4ab0-8c05-77f59a4e4ab7	1	2012-07-24
13668-016-25	EA - Each	13668-016	4a4033e0-7e86-4f19-b1bb-78e491e346c7	1	2012-07-24
13668-016-60	EA - Each	13668-016	076ddbf6-9456-4c19-a33c-8f7e4c55770f	1	2012-07-24
13668-016-61	EA - Each	13668-016	4da5dee0-92ef-4822-8d89-cf2b1b093195	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVETIRACETAM	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]	13
LEVETIRACETAM	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]	13
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]	13
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]	13
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]	13
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]	13
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]	13
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]	13
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]	13
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]	13
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]	13
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]	13
LEVETIRACETAM	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM TABLET [MAJOR PHARMACEUTICALS]	8
LEVETIRACETAM	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM TABLET [MAJOR PHARMACEUTICALS]	8
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LEVETIRACETAM TABLET [MAJOR PHARMACEUTICALS]	8
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LEVETIRACETAM TABLET [MAJOR PHARMACEUTICALS]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVETIRACETAM TABLET [MAJOR PHARMACEUTICALS]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LEVETIRACETAM TABLET [MAJOR PHARMACEUTICALS]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVETIRACETAM TABLET [MAJOR PHARMACEUTICALS]	8
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LEVETIRACETAM TABLET [MAJOR PHARMACEUTICALS]	8
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	LEVETIRACETAM TABLET [MAJOR PHARMACEUTICALS]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVETIRACETAM TABLET [MAJOR PHARMACEUTICALS]	8
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LEVETIRACETAM TABLET [MAJOR PHARMACEUTICALS]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEVETIRACETAM TABLET [MAJOR PHARMACEUTICALS]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LEVETIRACETAM TABLET [MAJOR PHARMACEUTICALS]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVETIRACETAM TABLET [MAJOR PHARMACEUTICALS]	8
LEVETIRACETAM	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]	7
LEVETIRACETAM	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]	7
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]	7
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]	7
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]	7
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]	7
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]	7
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]	7
LEVETIRACETAM	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM TABLET [STAT RX USA LLC]	3
LEVETIRACETAM	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM TABLET [STAT RX USA LLC]	3
LEVETIRACETAM	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM TABLET [REBEL DISTRIBUTORS CORP]	1
LEVETIRACETAM	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13668-016	LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]	27	Current NDC, Legacy NDC, 5 package rows	20250201_6ab24168-058d-496e-9023-da8ee6353eb3.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	OWP Pharmaceuticals, Inc.	e662bf5b-c81c-4bcd-ba2e-552df95ca6f9	2025-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078858 application number: ANDA078858
Levetiracetam	LEVETIRACETAM	PD-Rx Pharmaceuticals, Inc.	c2177034-e164-453c-be02-1cf91ce27a07	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078858 application number: ANDA078858
Levetiracetam	LEVETIRACETAM	Torrent Pharmaceuticals Limited	6ab24168-058d-496e-9023-da8ee6353eb3	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078858 application number: ANDA078858 ndc (product): 13668-016
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	b738377c-035e-4b2e-9909-0a8fe07aa0fb	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078858 application number: ANDA078858

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
387003	levETIRAcetam 1000 MG Oral Tablet	PSN	6ab24168-058d-496e-9023-da8ee6353eb3	27
311288	levETIRAcetam 250 MG Oral Tablet	PSN	6ab24168-058d-496e-9023-da8ee6353eb3	27
311289	levETIRAcetam 500 MG Oral Tablet	PSN	6ab24168-058d-496e-9023-da8ee6353eb3	27
311290	levETIRAcetam 750 MG Oral Tablet	PSN	6ab24168-058d-496e-9023-da8ee6353eb3	27
387003	levetiracetam 1000 MG Oral Tablet	SCD	6ab24168-058d-496e-9023-da8ee6353eb3	27
311288	levetiracetam 250 MG Oral Tablet	SCD	6ab24168-058d-496e-9023-da8ee6353eb3	27
311289	levetiracetam 500 MG Oral Tablet	SCD	6ab24168-058d-496e-9023-da8ee6353eb3	27
311290	levetiracetam 750 MG Oral Tablet	SCD	6ab24168-058d-496e-9023-da8ee6353eb3	27
387003	levETIRAcetam 1000 MG Oral Tablet	PSN	98bae5bb-729b-4a36-b429-5ee25aa80411	7
311289	levETIRAcetam 500 MG Oral Tablet	PSN	98bae5bb-729b-4a36-b429-5ee25aa80411	7
311290	levETIRAcetam 750 MG Oral Tablet	PSN	98bae5bb-729b-4a36-b429-5ee25aa80411	7
387003	levetiracetam 1000 MG Oral Tablet	SCD	98bae5bb-729b-4a36-b429-5ee25aa80411	7
311289	levetiracetam 500 MG Oral Tablet	SCD	98bae5bb-729b-4a36-b429-5ee25aa80411	7
311290	levetiracetam 750 MG Oral Tablet	SCD	98bae5bb-729b-4a36-b429-5ee25aa80411	7
311288	levETIRAcetam 250 MG Oral Tablet	PSN	6d71e14f-8092-444c-afa1-2b79d69d81e6	3
311289	levETIRAcetam 500 MG Oral Tablet	PSN	6d71e14f-8092-444c-afa1-2b79d69d81e6	3
311290	levETIRAcetam 750 MG Oral Tablet	PSN	6d71e14f-8092-444c-afa1-2b79d69d81e6	3
311288	levetiracetam 250 MG Oral Tablet	SCD	6d71e14f-8092-444c-afa1-2b79d69d81e6	3
311289	levetiracetam 500 MG Oral Tablet	SCD	6d71e14f-8092-444c-afa1-2b79d69d81e6	3
311290	levetiracetam 750 MG Oral Tablet	SCD	6d71e14f-8092-444c-afa1-2b79d69d81e6	3
387003	levETIRAcetam 1000 MG Oral Tablet	PSN	76c7e13d-37a0-4131-a1f1-fd5af0f60d3e	1
311288	levETIRAcetam 250 MG Oral Tablet	PSN	76c7e13d-37a0-4131-a1f1-fd5af0f60d3e	1
311289	levETIRAcetam 500 MG Oral Tablet	PSN	76c7e13d-37a0-4131-a1f1-fd5af0f60d3e	1
311290	levETIRAcetam 750 MG Oral Tablet	PSN	76c7e13d-37a0-4131-a1f1-fd5af0f60d3e	1
387003	levetiracetam 1000 MG Oral Tablet	SCD	76c7e13d-37a0-4131-a1f1-fd5af0f60d3e	1
311288	levetiracetam 250 MG Oral Tablet	SCD	76c7e13d-37a0-4131-a1f1-fd5af0f60d3e	1
311289	levetiracetam 500 MG Oral Tablet	SCD	76c7e13d-37a0-4131-a1f1-fd5af0f60d3e	1
311290	levetiracetam 750 MG Oral Tablet	SCD	76c7e13d-37a0-4131-a1f1-fd5af0f60d3e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-016-05	13668001605	500 TABLET in 1 BOTTLE (13668-016-05)	500 tablet	2009-01-15	0000-00-00	No	No	Current
13668-016-12	13668001612	120 TABLET in 1 BOTTLE (13668-016-12)	120 tablet	2009-01-15	0000-00-00	No	No	Current
13668-016-25	13668001625	250 TABLET in 1 BOTTLE (13668-016-25)	250 tablet	2009-01-15	0000-00-00	No	No	Current
13668-016-60	13668001660	60 TABLET in 1 BOTTLE (13668-016-60)	60 tablet	2009-01-15	0000-00-00	No	No	Current
13668-016-61	13668001661	50 TABLET in 1 CARTON (13668-016-61)	50 tablet	2009-01-15	0000-00-00	No	No	Current
13668-016-67	13668001667	800 TABLET in 1 BOTTLE (13668-016-67)	800 tablet	2009-01-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levetiracetam	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc.	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	27
Levetiracetam	Major Pharmaceuticals	2022-06-21	HUMAN PRESCRIPTION DRUG LABEL	14
Levetiracetam	Physicians Total Care, Inc.	2012-05-09	HUMAN PRESCRIPTION DRUG LABEL	7
LEVETIRACETAM - STAT RX USA LLC	STAT RX USA LLC	2011-12-01	HUMAN PRESCRIPTION DRUG LABEL	3
Levetiracetam	Rebel Distributors Corp	2010-09-30	HUMAN PRESCRIPTION DRUG LABEL	1