JANSSEN COVID-19 VACCINE- jnj-78436735 suspension

Janssen COVID-19 Vaccine by

Drug Labeling and Warnings

Janssen COVID-19 Vaccine by is a Other medication manufactured, distributed, or labeled by Janssen Products, LP, Grand River Aseptic Manufacturing, Inc., Catalent Indiana, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 - 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

INGREDIENTS AND APPEARANCE

JANSSEN COVID-19 VACCINE 
jnj-78436735 suspension

Product Information
Product Type	VACCINE	Item Code (Source)	NDC: 59676-580
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
JNJ-78436735 (UNII: JT2NS6183B) (JNJ-78436735 - UNII:JT2NS6183B)	JNJ-78436735	50000000000 [PFU]  in 0.5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	YELLOW (colorless to slightly yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59676-580-05	10 in 1 CARTON
1	NDC: 59676-580-15	2.5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		01/04/2021

Labeler - Janssen Products, LP (804684207)

Establishment
Name	Address	ID/FEI	Business Operations
Grand River Aseptic Manufacturing, Inc.		005593490	MANUFACTURE(59676-580) , ANALYSIS(59676-580)

Establishment
Name	Address	ID/FEI	Business Operations
Catalent Indiana, LLC		172209277	MANUFACTURE(59676-580) , ANALYSIS(59676-580)