Levetiracetam

Product NDC: 68180-112
11-digit product format: 681800112
Labeler code: 68180
Product ID: 68180-112_24fe2e98-0b9f-4eea-a745-e26002329cec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA078154
Marketing category: ANDA
Marketing start: 2009-01-15
Substance: LEVETIRACETAM
Active strength: 250 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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078154-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15
A078154-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15
A078154-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078154-001	AB
A078154-002	AB
A078154-003	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 4 · 123 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	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A078154-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078154-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078154-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078154-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078154-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078154-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078154-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078154-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078154-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078154-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078154-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078154-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078154-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078154-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078154-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078154-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Levetiracetam
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVETIRACETAM	250 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
df661166-325d-4071-9bc1-f7bf992996d2	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
68180-112-02	Levetiracetam	500 in 1 BOTTLE	TABLET, FILM COATED	500	26
68180-112-09	Levetiracetam	90 in 1 BOTTLE	TABLET, FILM COATED	90	26
68180-112-16	Levetiracetam	120 in 1 BOTTLE	TABLET, FILM COATED	120	26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-112-02	EA - Each	68180-112	4fcdee0c-9554-4448-825a-a69b7c56a290	1	2012-07-24
68180-112-09	EA - Each	68180-112	fe595e97-23f4-48e3-b8ba-72f643766014	1	2012-07-24
68180-112-16	EA - Each	68180-112	07475e8a-1be0-4bc4-b109-593868641684	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVETIRACETAM	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
LEVETIRACETAM	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
LEVETIRACETAM	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	8
LEVETIRACETAM	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	8
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	8
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	8
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	8
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	8
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	8
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	8
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	8
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	8
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	8
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	8
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	8
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	8
LEVETIRACETAM	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM TABLET [DIRECT RX]	3
LEVETIRACETAM	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM TABLET [DIRECT RX]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVETIRACETAM TABLET [DIRECT RX]	3
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVETIRACETAM TABLET [DIRECT RX]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LEVETIRACETAM TABLET [DIRECT RX]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LEVETIRACETAM TABLET [DIRECT RX]	3
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	LEVETIRACETAM TABLET [DIRECT RX]	3
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LEVETIRACETAM TABLET [DIRECT RX]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVETIRACETAM TABLET [DIRECT RX]	3
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	LEVETIRACETAM TABLET [DIRECT RX]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	LEVETIRACETAM TABLET [DIRECT RX]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LEVETIRACETAM TABLET [DIRECT RX]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEVETIRACETAM TABLET [DIRECT RX]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LEVETIRACETAM TABLET [DIRECT RX]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVETIRACETAM TABLET [DIRECT RX]	3
LEVETIRACETAM	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
LEVETIRACETAM	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
LEVETIRACETAM	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
LEVETIRACETAM	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVETIRACETAM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-112	LEVETIRACETAM TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	23	Current NDC, Legacy NDC, 3 package rows	20240418_df661166-325d-4071-9bc1-f7bf992996d2.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	a1b28234-1f7c-40bf-80a7-6cc98b3839fe	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	1c26c0ad-9d37-45c5-9091-849509f4fc01	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	90e01877-abcb-4697-a7ed-9afe5ee77050	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	PD-Rx Pharmaceuticals, Inc.	c4b2da6a-ed50-4a54-90bd-32f76b178736	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	Lupin Pharmaceuticals, Inc.	df661166-325d-4071-9bc1-f7bf992996d2	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154 ndc (product): 68180-112
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	24f815ef-58e6-42b9-8137-adcd6c382aa6	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	9e3171c9-70e2-4725-8aca-c7f83773940d	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	Preferred Pharmaceuticals, Inc.	e31c6830-4647-4481-b4f1-494a52c48b1b	2025-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	Proficient Rx LP	6bdbc193-d86b-4bd5-8e88-4ea964d2cdde	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154

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
311288	levETIRAcetam 250 MG Oral Tablet	PSN	9e3171c9-70e2-4725-8aca-c7f83773940d	1007
311288	levetiracetam 250 MG Oral Tablet	SCD	9e3171c9-70e2-4725-8aca-c7f83773940d	1007
387003	levETIRAcetam 1000 MG Oral Tablet	PSN	df661166-325d-4071-9bc1-f7bf992996d2	26
311288	levETIRAcetam 250 MG Oral Tablet	PSN	df661166-325d-4071-9bc1-f7bf992996d2	26
311289	levETIRAcetam 500 MG Oral Tablet	PSN	df661166-325d-4071-9bc1-f7bf992996d2	26
311290	levETIRAcetam 750 MG Oral Tablet	PSN	df661166-325d-4071-9bc1-f7bf992996d2	26
387003	levetiracetam 1000 MG Oral Tablet	SCD	df661166-325d-4071-9bc1-f7bf992996d2	26
311288	levetiracetam 250 MG Oral Tablet	SCD	df661166-325d-4071-9bc1-f7bf992996d2	26
311289	levetiracetam 500 MG Oral Tablet	SCD	df661166-325d-4071-9bc1-f7bf992996d2	26
311290	levetiracetam 750 MG Oral Tablet	SCD	df661166-325d-4071-9bc1-f7bf992996d2	26
311288	levETIRAcetam 250 MG Oral Tablet	PSN	f691fe85-a3dd-40b8-83ac-c1fa27907e6a	3
311288	levetiracetam 250 MG Oral Tablet	SCD	f691fe85-a3dd-40b8-83ac-c1fa27907e6a	3
311288	levETIRAcetam 250 MG Oral Tablet	PSN	80f5349c-3910-4c69-9f56-cb552bf4f336	1
311288	levETIRAcetam 250 MG Oral Tablet	PSN	41a781b4-da67-4650-a99b-593fc34465da	1
311289	levETIRAcetam 500 MG Oral Tablet	PSN	80f5349c-3910-4c69-9f56-cb552bf4f336	1
311290	levETIRAcetam 750 MG Oral Tablet	PSN	80f5349c-3910-4c69-9f56-cb552bf4f336	1
311288	levetiracetam 250 MG Oral Tablet	SCD	80f5349c-3910-4c69-9f56-cb552bf4f336	1
311288	levetiracetam 250 MG Oral Tablet	SCD	41a781b4-da67-4650-a99b-593fc34465da	1
311289	levetiracetam 500 MG Oral Tablet	SCD	80f5349c-3910-4c69-9f56-cb552bf4f336	1
311290	levetiracetam 750 MG Oral Tablet	SCD	80f5349c-3910-4c69-9f56-cb552bf4f336	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-112-02	68180011202	500 TABLET, FILM COATED in 1 BOTTLE (68180-112-02)	2009-01-15	0000-00-00	No	No	Current
68180-112-09	68180011209	90 TABLET, FILM COATED in 1 BOTTLE (68180-112-09)	2009-01-15	0000-00-00	No	No	Current
68180-112-16	68180011216	120 TABLET, FILM COATED in 1 BOTTLE (68180-112-16)	2009-01-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levetiracetam	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2026-05-11	HUMAN PRESCRIPTION DRUG LABEL	26
Levetiracetam	Bryant Ranch Prepack	2026-04-02	HUMAN PRESCRIPTION DRUG LABEL	1007
Levetiracetam	REMEDYREPACK INC.	2024-04-15	HUMAN PRESCRIPTION DRUG LABEL	7
Levetiracetam	Clinical Solutions Wholesale, LLC	2022-10-24	HUMAN PRESCRIPTION DRUG LABEL	5
Levetiracetam	REMEDYREPACK INC.	2019-10-31	HUMAN PRESCRIPTION DRUG LABEL	3
LEVETIRACETAM	DIRECT RX	2015-11-06	HUMAN PRESCRIPTION DRUG LABEL	3
Levetiracetam	Aidarex Pharmaceuticals LLC	2014-01-06	HUMAN PRESCRIPTION DRUG LABEL	1
Levetiracetam Tablets 250 mg, 500 mg and 750 mg	Rebel Distributors Corp \| PSS World Medical, Inc. \| STAT RX USA LLC \| Dispensing Solutions, Inc. \| SCRIPT PAK \| Keltman Pharmaceuticals, Inc. \| Rebel Distirbutors Corp.	2012-09-26	HUMAN PRESCRIPTION DRUG LABEL	1