IMITREX- sumatriptan spray 
GlaxoSmithKline Manufacturing SpA

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PRINCIPAL DISPLAY PANEL

NDC 0173-0523-00

IMITREX®

(SUMATRIPTAN)

NASAL SPRAY

20 mg

0.1 mL per unit

For Intranasal Use Only

Each unit dose nasal spray contains 20 mg of sumatriptan.

1 Spray per unit.

Do not test before use.

Rx only

6 Nasal Spray Units

©2015, the GSK group of companies

 
10000000135321 Rev. 6/15
Imitrex Nasal 20 mg 6 count carton

PRINCIPAL DISPLAY PANEL

NDC 0173-0524-00

IMITREX®

(SUMATRIPTAN)

NASAL SPRAY

5 mg

0.1 mL per unit

For Intranasal Use Only

Each unit dose nasal spray contains 5 mg of sumatriptan.

1 Spray per unit.

Do not test before use.

Rx only

6 Nasal Spray Units

©2015, the GSK group of companies

 
10000000135323 Rev. 6/15
Imitrex Nasal 5 mg 6 count carton
IMITREX 
sumatriptan spray
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:12064-014
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SUMATRIPTAN (UNII: 8R78F6L9VO) (SUMATRIPTAN - UNII:8R78F6L9VO) SUMATRIPTAN5 mg
Inactive Ingredients
Ingredient NameStrength
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SULFURIC ACID (UNII: O40UQP6WCF)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12064-014-006 in 1 BOX10/10/1997
11 in 1 CONTAINER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02062610/10/1997
IMITREX 
sumatriptan spray
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:12064-013
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SUMATRIPTAN (UNII: 8R78F6L9VO) (SUMATRIPTAN - UNII:8R78F6L9VO) SUMATRIPTAN20 mg
Inactive Ingredients
Ingredient NameStrength
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SULFURIC ACID (UNII: O40UQP6WCF)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12064-013-006 in 1 BOX09/18/1997
11 in 1 CONTAINER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02062609/18/1997
Labeler - GlaxoSmithKline Manufacturing SpA (338471078)

Revised: 11/2017
Document Id: d5d007cb-f6c3-4ec0-adb2-982fd6c1f4aa
Set id: 0ff9cd0c-299e-44c0-9bda-330543a065ed
Version: 2
Effective Time: 20171114
 
GlaxoSmithKline Manufacturing SpA