levetiracetam

Product NDC: 72205-037
11-digit product format: 722050037
Labeler code: 72205
Product ID: 72205-037_e0ff0141-0572-43f6-b9be-ea5f868abfba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levetiracetam
Dosage form: SOLUTION
Route: ORAL
Labeler: Novadoz Pharmaceuticals LLC
Application: ANDA214757
Marketing category: ANDA
Marketing start: 2022-07-16
Substance: LEVETIRACETAM
Active strength: 100 mg/mL
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#

Ingredient, Strength table
Ingredient	Strength
LEVETIRACETAM	100 mg/mL

Field, Values table
Field	Values
Unii	44YRR34555
Rxcui	403884

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72205-037-72	levetiracetam	473 mL in 1 BOTTLE, PLASTIC	SOLUTION	473		2

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72205-037-72	ML - Milliliter	72205-037	68ec6dd6-d18d-43a0-89ac-6b18043a3b72	1	2023-05-05

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72205-037	LEVETIRACETAM SOLUTION [NOVADOZ PHARMACEUTICALS LLC]	2	Current NDC, Legacy NDC, 1 package rows	20241030_1ec4c05d-7fba-4c02-a3bf-4343a8a421d5.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
44YRR34555	LEVETIRACETAM	102767-28-2	LEVETIRACETAM

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
403884	levETIRAcetam 100 MG in 1 mL Oral Solution	PSN	ba18ead0-69d7-453a-badc-cd6ad376d18e	100
403884	levetiracetam 100 MG/ML Oral Solution	SCD	ba18ead0-69d7-453a-badc-cd6ad376d18e	100
403884	levetiracetam 100 MG per 1 ML Oral Solution	SY	ba18ead0-69d7-453a-badc-cd6ad376d18e	100
403884	levetiracetam 1000 MG per 10 ML Oral Solution	SY	ba18ead0-69d7-453a-badc-cd6ad376d18e	100
403884	levetiracetam 1500 MG per 15 ML Oral Solution	SY	ba18ead0-69d7-453a-badc-cd6ad376d18e	100
403884	levetiracetam 500 MG per 5 ML Oral Solution	SY	ba18ead0-69d7-453a-badc-cd6ad376d18e	100
403884	levETIRAcetam 100 MG in 1 mL Oral Solution	PSN	1ec4c05d-7fba-4c02-a3bf-4343a8a421d5	2
403884	levetiracetam 100 MG/ML Oral Solution	SCD	1ec4c05d-7fba-4c02-a3bf-4343a8a421d5	2
403884	levetiracetam 100 MG per 1 ML Oral Solution	SY	1ec4c05d-7fba-4c02-a3bf-4343a8a421d5	2
403884	levetiracetam 1000 MG per 10 ML Oral Solution	SY	1ec4c05d-7fba-4c02-a3bf-4343a8a421d5	2
403884	levetiracetam 1500 MG per 15 ML Oral Solution	SY	1ec4c05d-7fba-4c02-a3bf-4343a8a421d5	2
403884	levetiracetam 500 MG per 5 ML Oral Solution	SY	1ec4c05d-7fba-4c02-a3bf-4343a8a421d5	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72205-037-72	72205003772	473 mL in 1 BOTTLE, PLASTIC (72205-037-72)	473 ml	2022-07-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
levetiracetam	Bryant Ranch Prepack	2026-05-06	HUMAN PRESCRIPTION DRUG LABEL	100
levetiracetam	Novadoz Pharmaceuticals LLC \| MSN Pharmaceuticals Inc.	2024-08-28	Human Prescription Drug Label	2