NDC 61434-043

SPIKEVAX

Covid-19 Vaccine, Mrna

SPIKEVAX is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Catalent Indiana, Llc. The primary component is Elasomeran.

Product ID61434-043_05780332-1acb-4683-9849-d0cf5faa7a67
NDC61434-043
Product TypeVaccine
Proprietary NameSPIKEVAX
Generic NameCovid-19 Vaccine, Mrna
Dosage FormInjection, Suspension
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2022-04-01
Marketing CategoryBLA /
Application NumberBLA125752
Labeler NameCatalent Indiana, LLC
Substance NameELASOMERAN
Active Ingredient Strength0 mg/.5mL
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 61434-043-02

120 CARTON in 1 CASE (61434-043-02) > 10 VIAL in 1 CARTON (61434-043-01) > 5.5 mL in 1 VIAL (61434-043-00)
Marketing Start Date2022-04-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "SPIKEVAX" or generic name "Covid-19 Vaccine, Mrna"

NDCBrand NameGeneric Name
61434-043SPIKEVAXCOVID-19 Vaccine, mRNA
80777-100SpikevaxCOVID-19 Vaccine, mRNA
0069-2025ComirnatyCOVID-19 Vaccine, mRNA

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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