IMITREX- sumatriptan succinate injection 
Glaxo Operations UK Ltd

----------

Imitrex Injection
(Sumatriptan succinate)

PRINCIPAL DISPLAY PANEL

NDC 0173-0739-02

IMITREX®

(SUMATRIPTAN SUCCINATE)

INJECTION

4 mg

0.5 mL

For subcutaneous injection only.

2 Single-Dose Syringe Cartridges

Rx only

 
10000000109572 Rev. 8/12
Imitrex Injection 4mg cartridge label

PRINCIPAL DISPLAY PANEL

NDC 0173-0478-00

IMITREX®

(SUMATRIPTAN SUCCINATE)

INJECTION

6 mg

0.5 mL

For subcutaneous injection only.

Rx only

2 Single-Dose Syringe Cartridges

 
10000000109517 Rev. 9/12
Imitrex Injection 6mg cartridge label

PRINCIPAL DISPLAY PANEL

NDC 0173-0449-02

IMITREX®

(SUMATRIPTAN SUCCINATE)

INJECTION

6 mg

0.5 mL

For subcutaneous injection only.

Single-dose vial. Discard unused portion.

5 Single-Dose Vials

Rx only

©2016 the GSK group of companies

 
10000000143924 Rev. 11/16
imitrex injection 6mg vial carton

PRINCIPAL DISPLAY PANEL

NDC 0173-0479-00

IMITREX

STATdose SYSTEM®

6 mg

This carton contains:

•
Imitrex®

(sumatriptan succinate)

Injection

2 prefilled 0.5-mL syringe cartridges, each containing 6 mg of sumatriptan for subcutaneous injection only

•
1 Imitrex STATdose Pen®
•
1 Carrying Case
•
Instructions for Use/Information for the Patient
•
Prescribing Information

Rx only

©2017 the GSK group of companies

 
10000000145308 Rev. 1/17
Imitrex 6mg Statdose carton
IMITREX 
sumatriptan succinate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63379-003
Route of AdministrationSUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO) SUMATRIPTAN4 mg  in 0.5 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) 3.8 mg  in 0.5 mL
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorYELLOW (clear, colorless to pale yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63379-003-002 in 1 PACKAGE04/06/2006
10.5 mL in 1 SYRINGE; Type 0: Not a Combination Product
2NDC:63379-003-012 in 1 CARTON04/06/2006
20.5 mL in 1 SYRINGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02008004/06/2006
IMITREX 
sumatriptan succinate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63379-004
Route of AdministrationSUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO) SUMATRIPTAN6 mg  in 0.5 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) 3.5 mg  in 0.5 mL
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorYELLOW (clear, colorless to pale yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63379-004-002 in 1 PACKAGE01/23/1997
10.5 mL in 1 SYRINGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02008001/23/1997
IMITREX 
sumatriptan succinate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63379-005
Route of AdministrationSUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO) SUMATRIPTAN6 mg  in 0.5 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) 3.5 mg  in 0.5 mL
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorYELLOW (clear, colorless to pale yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63379-005-002 in 1 CARTON01/27/1997
10.5 mL in 1 SYRINGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02008001/27/1997
IMITREX 
sumatriptan succinate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63379-006
Route of AdministrationSUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO) SUMATRIPTAN6 mg  in 0.5 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) 3.5 mg  in 0.5 mL
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorYELLOW (clear, colorless to pale yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63379-006-005 in 1 CARTON02/23/1993
10.5 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02008002/23/1993
Labeler - Glaxo Operations UK Ltd (424738227)
Registrant - GlaxoSmithKline LLC (167380711)

Revised: 12/2017
Document Id: 156273cd-6e6c-4547-96ae-1776dd70c489
Set id: 26ab9ed3-5119-4ba0-bab9-2ef946b312fc
Version: 3
Effective Time: 20171205
 
Glaxo Operations UK Ltd