NDC Code(s) : 59310-610-31, 59310-610-33
Packager : Teva Respiratory, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CINQAIRReslizumab INJECTION, SOLUTION, CONCENTRATE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59310-610
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RESLIZUMAB(UNII: 35A26E427H)
(RESLIZUMAB - UNII:35A26E427H) 		RESLIZUMAB10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID(UNII: Q40Q9N063P)
SODIUM ACETATE(UNII: 4550K0SC9B)
SUCROSE(UNII: C151H8M554)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59310-610-311 in 1 CARTON 18/04/2016
110 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
2NDC:59310-610-331 in 1 CARTON 06/04/2017
210 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761033 04/18/2016

LABELER - Teva Respiratory, LLC(176697907)

PRINCIPAL DISPLAY PANEL

trade carton image

NDC 59310-610-31

Rx only 

  Must be Refrigerated Sterile

CINQAIR®  (reslizumab)  Injection  100 mg/10 mL (10 mg/mL)

For Intravenous Infusion Only 

  Dilute Prior to Administration

One Single-Use Vial 

Discard Unused Portion

TEVA

PRINCIPAL DISPLAY PANEL

Sample Carton Image

NDC 59310-610-33

Rx only 

  Must be Refrigerated

Sterile

CINQAIR®  (reslizumab)  Injection  100 mg/10 mL (10 mg/mL)

For Intravenous Infusion Only 

  Dilute Prior to Administration

One Single-Use Vial 

  Discard Unused Portion

TEVA