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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LINEZOLID(UNII: ISQ9I6J12J)
(LINEZOLID - UNII:ISQ9I6J12J) 		LINEZOLID600 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:40032-022-0220 in 1 BOTTLE Type 0: Not a Combination Product22/08/2016
2NDC:40032-022-05500 in 1 BOTTLE Type 0: Not a Combination Product22/08/2016
3NDC:40032-022-313 in 1 CARTON 22/08/2016
3NDC:40032-022-3010 in 1 BLISTER PACK Type 0: Not a Combination Product22/08/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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

Linezolid Tablets, 600 mg

Container Label

20 Count

20 count

500 Count

20 count

30 Units Dose Tablets - Carton Label

20 count