NDC Code(s) : 72606-001-07, 72606-001-03, 72606-001-08
Packager : CELLTRION USA, 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:72606-001
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
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
Product Characteristics
Color white Score no score
Shape OVAL Size 18 mm
Flavor Imprint Code CIC;1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72606-001-0720 in 1 BOTTLE Type 0: Not a Combination Product05/02/2019
2NDC:72606-001-033 in 1 CARTON 22/05/2020
210 in 1 BLISTER PACK Type 0: Not a Combination Product05/02/2019
3NDC:72606-001-0830 in 1 BOTTLE Type 0: Not a Combination Product22/05/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210702 04/25/2019

LABELER - CELLTRION USA, INC.(116587378)

REGISTRANT - CELLTRION, INC.(688836030)

Establishment
Name Address ID/FEI Business Operations
Celltrion Pharm, Inc. 689687234 manufacture(72606-001), analysis(72606-001), pack(72606-001), label(72606-001)

PRINCIPAL DISPLAY PANEL

Rx only NDC 72606-001-03

Linezolid Tablets

600 mg

30 Unit-dose (3×10) Tablets Celltrion USA, INC.

PRINCIPAL DISPLAY PANEL - 600 mg Bottle Label

Rx only NDC 72606-001-07

Linezolid Tablets

600 mg

20 Tablets Celltrion USA, INC.

PRINCIPAL DISPLAY PANEL - 600 mg Bottle Label

Rx only NDC 72606-001-08

Linezolid Tablets

600 mg

30 Tablets Celltrion USA, INC.

PRINCIPAL DISPLAY PANEL - 600 mg Bottle Label