Levetiracetam

Product NDC: 66689-028
11-digit product format: 666890028
Labeler code: 66689
Product ID: 66689-028_c0232b95-ecd0-413d-a8ea-e6721aa21fdd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: SOLUTION
Route: ORAL
Labeler: VistaPharm, LLC
Application: ANDA078976
Marketing category: ANDA
Marketing start: 2010-01-25
Marketing end: 0000-00-00
Substance: LEVETIRACETAM
Active strength: 100 mg/mL
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	66689-028		D	Discontinued by firm		2026-07-31
excluded package	package	66689-028	66689-028-50	D	Discontinued by firm		2026-07-31

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078976-001	LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA		2009-01-15

Application-product, TE code table
Application-product	TE code
A078976-001	AA

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66689-028-01	ML - Milliliter	66689-028	54873b8a-90c5-453e-bc14-4ce23bc212d2	1	2012-07-24
66689-028-50	ML - Milliliter	66689-028	a8c7728e-1bbd-4637-9c28-3865ce4ee85e	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Levetiracetam	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM SOLUTION [VISTAPHARM, INC]	2
Levetiracetam	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM SOLUTION [VISTAPHARM, INC]	2
acesulfame potassium	INACTIVE INGREDIENT	23OV73Q5G9	LEVETIRACETAM SOLUTION [VISTAPHARM, INC]	2
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	LEVETIRACETAM SOLUTION [VISTAPHARM, INC]	2
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	LEVETIRACETAM SOLUTION [VISTAPHARM, INC]	2
glycyrrhizin, ammoniated	INACTIVE INGREDIENT	3VRD35U26C	LEVETIRACETAM SOLUTION [VISTAPHARM, INC]	2
maltitol	INACTIVE INGREDIENT	D65DG142WK	LEVETIRACETAM SOLUTION [VISTAPHARM, INC]	2
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	LEVETIRACETAM SOLUTION [VISTAPHARM, INC]	2
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	LEVETIRACETAM SOLUTION [VISTAPHARM, INC]	2
trisodium citrate dihydrate	INACTIVE INGREDIENT	B22547B95K	LEVETIRACETAM SOLUTION [VISTAPHARM, INC]	2
water	INACTIVE INGREDIENT	059QF0KO0R	LEVETIRACETAM SOLUTION [VISTAPHARM, INC]	2

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

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66689-028-50	66689002850	5 TRAY in 1 CASE (66689-028-50) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (66689-028-01)	5 tray	2010-01-25	0000-00-00	No	No	Current