20052 Monza, Italy

W10521C015

ET01

Rev 05/10
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 50 MG - VIAL LABEL

NDC 0008-4990-01

Tygacil®

(tigecycline) for injection

50 mg tigecycline per vial

For I.V. Infusion Only

Contains 100 mg lactose monohydrate;

pH adjusted with HCl and if necessary, NaOH.

No preservatives.

Rx only

Wyeth®

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 50 MG - CARTON

NDC 0008-4990-02

Tygacil®

(tigecycline) for injection

50 mg

Tigecycline per vial

10 Single Use Vials

RECONSTITUTED SOLUTION MUST BE FURTHER DILUTED FOR I.V. INFUSION

Rx Only

Wyeth®

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 50 MG - VIAL LABEL

NDC 0008-4990-19

Tygacil®

(tigecycline) for injection

50 mg tigecycline per vial

For I.V. Infusion Only

Contains 100 mg lactose monohydrate;

pH adjusted with HCl and if necessary, NaOH.

No preservatives.

Rx only

Wyeth®

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 50 MG - CARTON

NDC 0008-4990-20

Tygacil®

(tigecycline) for injection

50 mg

tigecycline per vial

10 Single Use Vials

RECONSTITUTED SOLUTION MUST BE FURTHER DILUTED FOR I.V. INFUSION

Rx only

Wyeth®

TYGACIL 
tigecycline   injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0008-4990
Route of Administration INTRAVENOUS DEA Schedule      
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIGECYCLINE (TIGECYCLINE)  TIGECYCLINE 50 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID  
SODIUM HYDROXIDE  
LACTOSE MONOHYDRATE 100 mg  in 5 mL
Product Characteristics
Color      Score     
Shape  Size 
Flavor  Imprint Code 
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0008-4990-02 10 VIAL In 1 CARTON contains a VIAL, SINGLE-USE (0008-4990-01)
1 0008-4990-01 50 mL In 1 VIAL, SINGLE-USE This package is contained within the CARTON (0008-4990-02)
2 0008-4990-20 10 VIAL In 1 CARTON contains a VIAL, SINGLE-USE (0008-4990-19)
2 0008-4990-19 50 mL In 1 VIAL, SINGLE-USE This package is contained within the CARTON (0008-4990-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021821 06/01/2005 
Labeler - Wyeth Pharmaceuticals Company (071170729) 
Establishment
Name Address ID/FEI Operations
Patheon Italia S.p.A.  338336589 MANUFACTURE, ANALYSIS
Establishment
Name Address ID/FEI Operations
Wyeth Parenterals Division of Wyeth Holdings Corporation  828832100 MANUFACTURE, ANALYSIS
Revised: 05/2010Wyeth Pharmaceuticals Company