Levetiracetam

Product NDC: 13668-015
11-digit product format: 136680015
Labeler code: 13668
Product ID: 13668-015_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: 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVETIRACETAM	500 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
13668-015-05	Levetiracetam	500 in 1 BOTTLE	TABLET	500	27
13668-015-12	Levetiracetam	120 in 1 BOTTLE	TABLET	120	27
13668-015-17	Levetiracetam	1350 in 1 BOTTLE	TABLET	1350	27
13668-015-25	Levetiracetam	250 in 1 BOTTLE	TABLET	250	27
13668-015-60	Levetiracetam	60 in 1 BOTTLE	TABLET	60	27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-015-05	EA - Each	13668-015	48b5315f-077c-495d-ae41-6c2f46b9c73a	1	2012-07-24
13668-015-12	EA - Each	13668-015	b0a30f43-364c-4ba3-a312-6335e2b04e71	1	2012-07-24
13668-015-25	EA - Each	13668-015	61f29f8a-42ad-463e-8a0b-843f770c7127	1	2012-07-24
13668-015-60	EA - Each	13668-015	d4156be2-f103-4b0c-8a24-1eed51377649	1	2012-07-24
13668-015-62	EA - Each	13668-015	e4011203-455d-4fee-a220-6b62c7f53a42	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 [PD-RX PHARMACEUTICALS, INC.]	10
LEVETIRACETAM	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.]	10
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.]	10
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.]	10
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.]	10
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.]	10
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.]	10
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.]	10
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.]	10
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.]	10
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
13668-015	LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]	27	Current NDC, Legacy NDC, 5 package rows	20250201_6ab24168-058d-496e-9023-da8ee6353eb3.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
311289	levETIRAcetam 500 MG Oral Tablet	PSN	b738377c-035e-4b2e-9909-0a8fe07aa0fb	102
311289	levetiracetam 500 MG Oral Tablet	SCD	b738377c-035e-4b2e-9909-0a8fe07aa0fb	102
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
311289	levETIRAcetam 500 MG Oral Tablet	PSN	c2177034-e164-453c-be02-1cf91ce27a07	26
311289	levetiracetam 500 MG Oral Tablet	SCD	c2177034-e164-453c-be02-1cf91ce27a07	26
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
311289	levETIRAcetam 500 MG Oral Tablet	PSN	49e636e9-dc17-4df7-8bf0-bec82af73126	6
311289	levetiracetam 500 MG Oral Tablet	SCD	49e636e9-dc17-4df7-8bf0-bec82af73126	6
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
13668-015-05	13668001505	500 TABLET in 1 BOTTLE (13668-015-05)	500 tablet	2009-01-15	0000-00-00	No	No	Current
13668-015-12	13668001512	120 TABLET in 1 BOTTLE (13668-015-12)	120 tablet	2009-01-15	0000-00-00	No	No	Current
13668-015-17	13668001517	1350 TABLET in 1 BOTTLE (13668-015-17)	1350 tablet	2009-01-15	0000-00-00	No	No	Current
13668-015-25	13668001525	250 TABLET in 1 BOTTLE (13668-015-25)	250 tablet	2009-01-15	0000-00-00	No	No	Current
13668-015-60	13668001560	60 TABLET in 1 BOTTLE (13668-015-60)	60 tablet	2009-01-15	0000-00-00	No	No	Current
13668-015-62	13668001562	60 TABLET in 1 CARTON (13668-015-62)	60 tablet	2009-01-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levetiracetam	PD-Rx Pharmaceuticals, Inc.	2025-02-28	HUMAN PRESCRIPTION DRUG LABEL	26
Levetiracetam	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc.	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	27
Levetiracetam	Bryant Ranch Prepack	2024-08-12	HUMAN PRESCRIPTION DRUG LABEL	102
Levetiracetam	A-S Medication Solutions	2018-08-29	HUMAN PRESCRIPTION DRUG LABEL	6
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

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#