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NDC 49281-0519-25 FLUZONE QUADRIVALENT NORTHERN HEMISPHERE 7.5; 7.5; 7.5; 7.5 ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL Details
FLUZONE QUADRIVALENT NORTHERN HEMISPHERE 7.5; 7.5; 7.5; 7.5 ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL
FLUZONE QUADRIVALENT NORTHERN HEMISPHERE 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); INF.
Product Information
| NDC | 49281-0519 |
|---|---|
| Product ID | 49281-519_630e666a-9196-4d8c-9b96-7ee44f4daf5f |
| Associated GPIs | 1710002025E610 |
| GCN Sequence Number | 079642 |
| GCN Sequence Number Description | flu vacc qs 2019 (6-35mos)/PF SYRINGE 30MCG/0.25 INTRAMUSC |
| HIC3 | W7C |
| HIC3 Description | INFLUENZA VIRUS VACCINES |
| GCN | 46181 |
| HICL Sequence Number | 045682 |
| HICL Sequence Number Description | INFLUENZA VIRUS VACCINE QUADRIVAL 2019-20 (6 MOS-35 MOS)/PF |
| Brand/Generic | Brand |
| Proprietary Name | FLUZONE QUADRIVALENT NORTHERN HEMISPHERE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary 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/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA |
| Product Type | VACCINE |
| Dosage Form | INJECTION, SUSPENSION |
| Route | INTRAMUSCULAR |
| Active Ingredient Strength | 7.5; 7.5; 7.5; 7.5 |
| Active Ingredient Units | ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL |
| 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); INF |
| 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 49281-0519-25 (49281051925)
| NDC Package Code | 49281-519-25 |
|---|---|
| Billing NDC | 49281051925 |
| Package | 10 SYRINGE, GLASS in 1 PACKAGE (49281-519-25) / .25 mL in 1 SYRINGE, GLASS (49281-519-00) |
| Marketing Start Date | 2019-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |