Janssen COVID-19 Vaccine: Package Insert and Label Information (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 10 Vial Carton

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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
(click image for full-size original)
JANSSEN COVID-19 VACCINE ad26.cov2.s injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:59676-580
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ad26.COV2.S (Ad26.COV2.S) Ad26.COV2.S 50000000000 {VP} in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
Citric acid monohydrate
Trisodium citrate dihydrate
Alcohol
Hydroxypropyl betadex
Polysorbate 80
Sodium chloride
Sodium hydroxide
Hydrochloric acid
Water
Product Characteristics
Color YELLOW (colorless to slightly yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-580-15 10 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (59676-580-05)
1 NDC:59676-580-05 2.5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (59676-580-15)
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 Operations
Janssen 415960780 API MANUFACTURE (59676-580)
Establishment
Name Address ID/FEI Operations
Jannsen Biologics B.V. 409612918 API MANUFACTURE (59676-580)
Establishment
Name Address ID/FEI Operations
Grand River Aseptic Manufacturing, Inc. 005593490 MANUFACTURE (59676-580), ANALYSIS (59676-580)
Establishment
Name Address ID/FEI Operations
Emergent Manufacturing Operations Baltimore LLC 968316831 MANUFACTURE (59676-580), ANALYSIS (59676-580)
Establishment
Name Address ID/FEI Operations
Packaging Coordinators, LLC 078525133 PACK (59676-580), LABEL (59676-580)
Establishment
Name Address ID/FEI Operations
Catalent Indiana, LLC 172209277 MANUFACTURE (59676-580), PACK (59676-580), ANALYSIS (59676-580)

Revised: 04/2021 Janssen Products, LP

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