JANSSEN COVID-19 VACCINE- jnj-78436735 suspension 
Janssen Products, LP

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Janssen COVID-19 Vaccine

PRINCIPAL DISPLAY PANEL - 2.5 mL Vial Label

10554801

For use
under
Emergency
Use
Authorization

Janssen COVID-19
Vaccine

5 doses of 0.5 mL

Intramuscular Injection

No Preservative

For EXP: www.vaxcheck.jnj

After first use, hold at
2°C to 8°C (36°F to 46°F).
Discard after 6 hours.

Record date and time
of first use:

LOT

Principal Display Panel - 2.5 mL Vial Label

PRINCIPAL DISPLAY PANEL - 10 Vial Carton

OPEN
HERE

NDC 59676-580-15
No Preservative

10 Multi-dose Vials
Each vial contains 5 doses of 0.5 mL

Janssen COVID-19 Vaccine
SUSPENSION FOR INTRAMUSCULAR INJECTION

For use under Emergency Use Authorization

Attention: After first use, hold at 2°C to 8°C
(36°F to 46°F). Discard after 6 hours.
Do not freeze.

janssen

Principal Display Panel - 10 Vial Carton
JANSSEN COVID-19 VACCINE 
jnj-78436735 suspension
Product Information
Product TypeVACCINEItem Code (Source)NDC:59676-580
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
JNJ-78436735 (UNII: JT2NS6183B) (JNJ-78436735 - UNII:JT2NS6183B) JNJ-7843673550000000000 [PFU]  in 0.5 mL
Inactive Ingredients
Ingredient NameStrength
Citric acid monohydrate (UNII: 2968PHW8QP)  
Trisodium citrate dihydrate (UNII: B22547B95K)  
Alcohol (UNII: 3K9958V90M)  
Hydroxypropyl betadex (UNII: 1I96OHX6EK)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Sodium chloride (UNII: 451W47IQ8X)  
Sodium hydroxide (UNII: 55X04QC32I)  
Hydrochloric acid (UNII: QTT17582CB)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
ColorYELLOW (colorless to slightly yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59676-580-0510 in 1 CARTON
1NDC:59676-580-152.5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other01/04/2021
Labeler - Janssen Products, LP (804684207)
Establishment
NameAddressID/FEIBusiness Operations
Grand River Aseptic Manufacturing, Inc.005593490MANUFACTURE(59676-580) , ANALYSIS(59676-580)
Establishment
NameAddressID/FEIBusiness Operations
Catalent Indiana, LLC172209277MANUFACTURE(59676-580) , ANALYSIS(59676-580)

Revised: 1/2021
Document Id: d7618e70-6387-11ea-9429-f017fc2ca371
Set id: 14a822ff-f353-49f9-a7f2-21424b201e3b
Version: 3
Effective Time: 20210112
 
Janssen Products, LP