| NDC Code | 49281-126-65 |
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| Package Description | 5 SYRINGE, GLASS in 1 PACKAGE (49281-126-65) / .5 mL in 1 SYRINGE, GLASS (49281-126-88) |
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| Product NDC | 49281-126 |
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| Product Type Name | VACCINE |
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| Proprietary Name | Fluzone High Dose Northern Hemisphere |
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| Non-Proprietary Name | Influenza A Virus A/switzerland/6849/2025 Ivr-278 (a/missouri/11/2025 Pdm09-like Virus) (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/michigan/105/2025 San-049a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/tokyo/eis13-175/2025 Antigen (formaldehyde Inactivated) |
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| Dosage Form | INJECTION, SUSPENSION |
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| Usage | INTRAMUSCULAR |
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| Start Marketing Date | 20260702 |
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| End Marketing Date | 20270630 |
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| Marketing Category Name | BLA |
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| Application Number | BLA103914 |
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| Manufacturer | Sanofi Vaccines US Inc. |
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| Substance Name | INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/MICHIGAN/105/2025 SAN-049A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/TOKYO/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED) |
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| Strength | 60; 60; 60 |
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| Strength Unit | ug/.5mL; ug/.5mL; ug/.5mL |
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