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

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 Identifiers#

Field, Values table
Field	Values
Unii	44YRR34555
Rxcui	311288, 311289, 311290, 387003

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

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	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

Levetiracetam

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#