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NDC 49281-0405-65 FLUZONE High-Dose 60; 60; 60 ug/.5mL; ug/.5mL; ug/.5mL Details
FLUZONE High-Dose 60; 60; 60 ug/.5mL; ug/.5mL; ug/.5mL
FLUZONE High-Dose is a INTRAMUSCULAR INJECTION, SUSPENSION in the VACCINE category. It is labeled and distributed by Sanofi Pasteur Inc.. The primary component is INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED).
Product Information
| NDC | 49281-0405 |
|---|---|
| Product ID | 49281-405_a1291f5b-2485-423a-b128-a3bc75ab738a |
| Associated GPIs | 1710002023E620 |
| GCN Sequence Number | 079816 |
| GCN Sequence Number Description | flu vacc ts2019-20(65yr up)/PF SYRINGE 180MCG/0.5 INTRAMUSC |
| HIC3 | W7C |
| HIC3 Description | INFLUENZA VIRUS VACCINES |
| GCN | 46395 |
| HICL Sequence Number | 045771 |
| HICL Sequence Number Description | INFLUENZA VIRUS VACCINE TRIVAL SPLIT 2019-2020(65 YR UP)/PF |
| Brand/Generic | Brand |
| Proprietary Name | FLUZONE High-Dose |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | influenza a virus a/michigan/45/2015 x-275 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/singapore/infimh-16-0019/2016 ivr-186 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/maryland/15/2016 bx-69a (a b/colorado/6/2017 |
| Product Type | VACCINE |
| Dosage Form | INJECTION, SUSPENSION |
| Route | INTRAMUSCULAR |
| Active Ingredient Strength | 60; 60; 60 |
| Active Ingredient Units | ug/.5mL; ug/.5mL; ug/.5mL |
| Substance Name | INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED) |
| Labeler Name | Sanofi Pasteur Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA103914 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 49281-0405-65 (49281040565)
| NDC Package Code | 49281-405-65 |
|---|---|
| Billing NDC | 49281040565 |
| Package | 10 SYRINGE, GLASS in 1 PACKAGE (49281-405-65) / .5 mL in 1 SYRINGE, GLASS (49281-405-88) |
| Marketing Start Date | 2019-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |