NDC Code(s) : 12064-014-00, 12064-013-00
Packager : GlaxoSmithKline Manufacturing SpA

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IMITREXsumatriptan SPRAY
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12064-014
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUMATRIPTAN(UNII: 8R78F6L9VO)
(SUMATRIPTAN - UNII:8R78F6L9VO) 		SUMATRIPTAN5 mg
Inactive Ingredients
Ingredient Name Strength
POTASSIUM PHOSPHATE, MONOBASIC(UNII: 4J9FJ0HL51)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: 22ADO53M6F)
SULFURIC ACID(UNII: O40UQP6WCF)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:12064-014-006 in 1 BOX 10/10/1997
11 in 1 CONTAINER Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA020626 10/10/1997
IMITREXsumatriptan SPRAY
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12064-013
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUMATRIPTAN(UNII: 8R78F6L9VO)
(SUMATRIPTAN - UNII:8R78F6L9VO) 		SUMATRIPTAN20 mg
Inactive Ingredients
Ingredient Name Strength
POTASSIUM PHOSPHATE, MONOBASIC(UNII: 4J9FJ0HL51)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: 22ADO53M6F)
SULFURIC ACID(UNII: O40UQP6WCF)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:12064-013-006 in 1 BOX 18/09/1997
11 in 1 CONTAINER Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA020626 09/18/1997

PRINCIPAL DISPLAY PANEL

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