SPIKEVAX by Catalent Indiana, LLC

SPIKEVAX by

Drug Labeling and Warnings

SPIKEVAX by is a Other medication manufactured, distributed, or labeled by Catalent Indiana, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPIKEVAX- covid-19 vaccine, mrna injection, solution 
Catalent Indiana, LLC

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256-109-301Export Carton.jpg

SPIKEVAX 
covid-19 vaccine, mrna injection, solution
Product Information
Product TypeVACCINEItem Code (Source)NDC: 61434-061
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CX-038839 OMICRON (XBB.1.5) (UNII: 4F9QRS7ZV2) (CX-038839 OMICRON (XBB.1.5) - UNII:4F9QRS7ZV2) CX-038839 OMICRON (XBB.1.5)50 ug  in 0.5 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 61434-061-0110 in 1 CARTON
1NDC: 61434-061-002.5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
export only09/11/202303/02/2025
Labeler - Catalent Indiana, LLC (172209277)

Revised: 11/2024
Document Id: f85cc748-a8b7-43c2-851e-7b8a0c6f3c81
Set id: 1aea6699-253b-4007-b383-2f9a204a42e5
Version: 7
Effective Time: 20241124
 

Trademark Results [SPIKEVAX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPIKEVAX
SPIKEVAX
97037862 not registered Live/Pending
ModernaTx, Inc.
2021-09-21
SPIKEVAX
SPIKEVAX
90247367 not registered Live/Pending
ModernaTx, Inc.
2020-10-11
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