o dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about sharps disposal, and for specific information about safe sharps disposal in the state that you live in, go to the FDA’s website at:
HTTP://WWW.FDA.GOV/SAFESHARPSDISPOSAL
CLOSE
PRINCIPAL DISPLAY PANEL - NDC: 72126-007-02 - SYRINGE LABEL
Syringe Label
PRINCIPAL DISPLAY PANEL - NDC: 72126-007-02 - 1-COUNT TRAY LABEL
1-count Tray Label
PRINCIPAL DISPLAY PANEL - NDC: 72126-007-01 - 4-COUNT CARTON LABEL
4-count Carton Label
INGREDIENTS AND APPEARANCE
TEGSEDI
inotersen injection, solution
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72126-007
Route of Administration SUBCUTANEOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
INOTERSEN SODIUM (UNII: 950736UC77) (INOTERSEN - UNII:0IEO0F56LV) INOTERSEN SODIUM 284 mg in 1.5 mL
INACTIVE INGREDIENTS
Ingredient Name Strength
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
PRODUCT CHARACTERISTICS
Color YELLOW (colourless to pale yellow solution) Score
Shape Size
Flavor Imprint Code
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:72126-007-01 4 in 1 CARTON 10/05/2018
1 NDC:72126-007-02 1 in 1 TRAY
1 1.5 mL in 1 SYRINGE; 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
NDA NDA211172 10/05/2018
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8513207e-b55f-417b-9473-af785146a543 |
