SIVEXTRO (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 200 mg Bottle Label

NDC 72000-310-30
30 tablets

Sivextro® (tedizolid phosphate) tablets

200 mg per tablet

Rx only

Principal Display Panel -- 200 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 200 mg Tablet Blister Pack Carton

NDC 72000-310-06 6 tablets

Sivextro® (tedizolid phosphate) tablets

200 mg per tablet

Rx only

Principal Display Panel -- 200 mg Tablet Blister Pack Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 200 mg Vial Carton

NDC 72000-320-10 10 single-dose vials

Sivextro®
(tedizolid phosphate) for injection

200 mg per vial
For Intravenous Infusion

Rx only Sterile

Principal Display Panel -- 200 mg Vial Carton
(click image for full-size original)
SIVEXTRO tedizolid phosphate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72000-310
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TEDIZOLID PHOSPHATE (TEDIZOLID) TEDIZOLID PHOSPHATE 200 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
MANNITOL
CROSPOVIDONE (15 MPA.S AT 5%)
POVIDONE, UNSPECIFIED
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 14mm
Flavor Imprint Code TZD;200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72000-310-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:72000-310-06 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 6 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (72000-310-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205435 06/20/2014
SIVEXTRO tedizolid phosphate injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72000-320
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TEDIZOLID PHOSPHATE (TEDIZOLID) TEDIZOLID PHOSPHATE 200 mg in 4 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL 105 mg in 4 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72000-320-10 10 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
1 4 mL in 1 VIAL, GLASS This package is contained within the CARTON (72000-320-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205436 06/20/2014
Labeler — Nabriva Therapeutics US, Inc. (072863844)
Registrant — Merck Sharp & Dohme Corp. (001317601)

Revised: 04/2021 Nabriva Therapeutics US, Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.