NDC Code(s) : 47426-201-01
Packager : Heron Therapeutics, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CINVANTIaprepitant INJECTION, EMULSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47426-201
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
APREPITANT(UNII: 1NF15YR6UY)
(APREPITANT - UNII:1NF15YR6UY) 		APREPITANT130 mg in 18 mL
Inactive Ingredients
Ingredient Name Strength
EGG PHOSPHOLIPIDS(UNII: 1Z74184RGV)2602 mg in 18 mL
ALCOHOL(UNII: 3K9958V90M)513 mg in 18 mL
SODIUM OLEATE(UNII: 399SL044HN)87 mg in 18 mL
SOYBEAN OIL(UNII: 241ATL177A)1734 mg in 18 mL
SUCROSE(UNII: C151H8M554)973 mg in 18 mL
WATER(UNII: 059QF0KO0R)12142 mg in 18 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:47426-201-011 in 1 CARTON 01/03/2018
118 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209296 01/03/2018

LABELER - Heron Therapeutics, Inc.(102099843)

REGISTRANT - Heron Therapeutics, Inc.(102099843)

Establishment
Name Address ID/FEI Business Operations
Alcami Carolinas Corporation 832394733 manufacture(47426-201)

Establishment
Name Address ID/FEI Business Operations
Sharp Corporation 143696495 label(47426-201)

Establishment
Name Address ID/FEI Business Operations
Curia New Mexico, LLC 078268825 manufacture(47426-201)

Establishment
Name Address ID/FEI Business Operations
Pharma Packaging Solutions 928861723 label(47426-201)

Establishment
Name Address ID/FEI Business Operations
Glenmark Life Sciences, Ltd. 650283737 api manufacture(47426-201)

Establishment
Name Address ID/FEI Business Operations
Eurofins BioPharma Product Testing Columbia, Inc. 152144247 analysis(47426-201)

Establishment
Name Address ID/FEI Business Operations
SPS Pharma Services 279693795 analysis(47426-201)

Establishment
Name Address ID/FEI Business Operations
Particle Technology Group LLC, dba Particle Technology Labs 808076947 analysis(47426-201)

Establishment
Name Address ID/FEI Business Operations
Alcami Carolinas Corporation 079646861 label(47426-201)

Establishment
Name Address ID/FEI Business Operations
Alcami Carolinas Corporation 831351445 analysis(47426-201)

Establishment
Name Address ID/FEI Business Operations
SGS North America Inc. 049859261 analysis(47426-201)

PRINCIPAL DISPLAY PANEL

NDC 47426-201-01
Rx Only

CINVANTI ®
(aprepitant)
injectable emulsion

130 mg/18 mL
(7.2 mg/mL)

For Intravenous Use Only

Must be refrigerated. Store at
2°C-8°C (36°F-46°F). Do Not Freeze.

1 Sterile Single-Dose Vial
Discard Unused Portion

HERON
THERAPEUTICS

PRINCIPAL DISPLAY PANEL - 130 mg/18 mL Vial Carton

PRINCIPAL DISPLAY PANEL

NDC 47426-201-01
Rx Only

CINVANTI ®
(aprepitant)
injectable emulsion

130 mg/18 mL
(7.2 mg/mL)

For Intravenous Use Only

Must be refrigerated. Store at
2°C-8°C (36°F-46°F). Do Not Freeze.

1 Sterile Single-Dose Vial
Discard Unused Portion

Not For Sale

HERON
THERAPEUTICS

PRINCIPAL DISPLAY PANEL - 130 mg/18 mL Vial Carton - Not For Sale