NDC 40032-022-02
API & Excipient Details

Linezolid marketed by Novel Laboratories, Inc. under NDC Code 40032-022-02

NDC Code(s) : 40032-022-02, 40032-022-05, 40032-022-30, 40032-022-31
Packager : Novel Laboratories, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LinezolidLinezolid TABLET

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:40032-022
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LINEZOLID(UNII: ISQ9I6J12J) (LINEZOLID - UNII:ISQ9I6J12J)	LINEZOLID	600 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYDEXTROSE(UNII: VH2XOU12IE)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
TRIACETIN(UNII: XHX3C3X673)
POLYETHYLENE GLYCOL 1000(UNII: U076Q6Q621)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	18 mm
Flavor		Imprint Code	n022
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:40032-022-02	20 in 1 BOTTLE Type 0: Not a Combination Product	22/08/2016
2	NDC:40032-022-05	500 in 1 BOTTLE Type 0: Not a Combination Product	22/08/2016
3	NDC:40032-022-31	3 in 1 CARTON	22/08/2016
3	NDC:40032-022-30	10 in 1 BLISTER PACK Type 0: Not a Combination Product	22/08/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA207526	08/22/2016

LABELER - Novel Laboratories, Inc.(793518643)

REGISTRANT - Novel Laboratories, Inc.(793518643)

Establishment
Name	Address	ID/FEI	Business Operations
Novel Laboratories, Inc.		793518643	ANALYSIS(40032-022), MANUFACTURE(40032-022)

PRINCIPAL DISPLAY PANEL