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NDC 49281-0418-50 FLUZONE QUADRIVALENT NORTHERN HEMISPHERE 15; 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Details
FLUZONE QUADRIVALENT NORTHERN HEMISPHERE 15; 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
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/MICHIGAN/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE IN.
Product Information
| NDC | 49281-0418 |
|---|---|
| Product ID | 49281-418_630e666a-9196-4d8c-9b96-7ee44f4daf5f |
| Associated GPIs | 17100020251820 1710002025E620 |
| GCN Sequence Number | 078405 |
| GCN Sequence Number Description | flu vacc qs2018-19 36mos up/PF VIAL 60MCG/.5ML INTRAMUSC |
| HIC3 | W7C |
| HIC3 Description | INFLUENZA VIRUS VACCINES |
| GCN | 44726 |
| HICL Sequence Number | 044911 |
| HICL Sequence Number Description | INFLUENZA VIRUS VACCINE QUADRIVALENT 2018-19 (36 MOS UP)/PF |
| Brand/Generic | Brand |
| Proprietary Name | FLUZONE QUADRIVALENT NORTHERN HEMISPHERE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 HEM |
| Product Type | VACCINE |
| Dosage Form | INJECTION, SUSPENSION |
| Route | INTRAMUSCULAR |
| Active Ingredient Strength | 15; 15; 15; 15 |
| Active Ingredient Units | ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |
| Substance 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); INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE IN |
| 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 49281-0418-50 (49281041850)
| NDC Package Code | 49281-418-50 |
|---|---|
| Billing NDC | 49281041850 |
| Package | 10 SYRINGE, GLASS in 1 PACKAGE (49281-418-50) / .5 mL in 1 SYRINGE, GLASS (49281-418-88) |
| Marketing Start Date | 2019-01-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |