NDC Code(s) : 27505-004-01, 27505-004-05
Packager : MDD US Operations, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

APOKYNAPOMORPHINE HYDROCHLORIDE INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27505-004
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
APOMORPHINE HYDROCHLORIDE(UNII: F39049Y068)
(APOMORPHINE - UNII:N21FAR7B4S) 		APOMORPHINE HYDROCHLORIDE30 mg in 3 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM METABISULFITE(UNII: 4VON5FNS3C)3 mg in 3 mL
BENZYL ALCOHOL(UNII: LKG8494WBH)15 mg in 3 mL
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:27505-004-055 in 1 CARTON 07/02/2004
1NDC:27505-004-013 mL in 1 CARTRIDGE Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021264 07/02/2004

LABELER - MDD US Operations, LLC(087875626)

Establishment
Name Address ID/FEI Business Operations
Covance Laboratories 213137276 analysis(27505-004)

Establishment
Name Address ID/FEI Business Operations
Macfarlan Smith Limited 214057671 api manufacture(27505-004)

Establishment
Name Address ID/FEI Business Operations
Wickham Laboratories Limited 228216353 analysis(27505-004)

Establishment
Name Address ID/FEI Business Operations
Vetter Pharma Fertigung GmbH & Co. KG 316126754 manufacture(27505-004), analysis(27505-004)

Establishment
Name Address ID/FEI Business Operations
Kennet Bioservices Ltd 399663194 analysis(27505-004), manufacture(27505-004)

Establishment
Name Address ID/FEI Business Operations
A+ Secure Packaging, LLC 963589036 pack(27505-004), label(27505-004)

PRINCIPAL DISPLAY PANEL

NDC 27505-004-05

5 × 3 mL cartridges for single-patient-use

Rx only

APOKYN ®

(apomorphine hydrochloride injection)

30 mg/3 mL (10 mg/mL)

For use only with the APOKYN ® Pen for

subcutaneous administration.

Not for Intravenous Use.

Single-patient-use with pen injector

CTN10029.01

MDD US Operations, LLC ®

PRINCIPAL DISPLAY PANEL - 30 mg/3 mL Cartridge Carton