NDC 33332-418
AFLURIA QUADRIVALENT
Influenza A Virus A/singapore/gp1908/2015 Ivr-180a (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/maryland/15/2016 Antigen (propiolactone Inactivated), And Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated)
AFLURIA QUADRIVALENT is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Seqirus Pty Ltd. The primary component is Influenza A Virus A/singapore/gp1908/2015 Ivr-180a (h1n1) Antigen (propiolactone Inactivated); Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (propiolactone Inactivated); Influenza B Virus B/maryland/15/2016 Antigen (propiolactone Inactivated); Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated).
| Product ID | 33332-418_0e9dddc2-f132-4357-ad4f-0307408a2130 |
| NDC | 33332-418 |
| Product Type | Vaccine |
| Proprietary Name | AFLURIA QUADRIVALENT |
| Generic Name | Influenza A Virus A/singapore/gp1908/2015 Ivr-180a (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/maryland/15/2016 Antigen (propiolactone Inactivated), And Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated) |
| Dosage Form | Injection, Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2017-08-16 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125254 |
| Labeler Name | Seqirus Pty Ltd |
| Substance Name | INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| Active Ingredient Strength | 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 33332-418-10
1 VIAL, MULTI-DOSE in 1 CARTON (33332-418-10) > 5 mL in 1 VIAL, MULTI-DOSE (33332-418-11)
| Marketing Start Date | 2017-08-16 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 33332-418-11 [33332041811]
AFLURIA QUADRIVALENT INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA125254 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2017-08-16 |
| Marketing End Date | 2019-11-01 |
NDC 33332-418-10 [33332041810]
AFLURIA QUADRIVALENT INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA125254 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2017-08-16 |
| Marketing End Date | 2019-11-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) | 15 ug/.5mL |
NDC Crossover Matching brand name "AFLURIA QUADRIVALENT" or generic name "Influenza A Virus A/singapore/gp1908/2015 Ivr-180a (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/maryland/15/2016 Antigen (propiolactone Inactivated), And Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated)"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 33332-219 | Afluria Quadrivalent | INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-220 | Afluria Quadrivalent | INFLUENZA A VIRUS A/VICTORIA/2454/2019 IVR-207 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-221 | Afluria Quadrivalent | INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/CAMBODIA/E0826360/2020 IVR-224 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-318 | AFLURIA QUADRIVALENT | INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED), AND INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-319 | Afluria Quadrivalent | INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-320 | Afluria Quadrivalent | INFLUENZA A VIRUS A/VICTORIA/2454/2019 IVR-207 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-321 | Afluria Quadrivalent | INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/CAMBODIA/E0826360/2020 IVR-224 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-322 | Afluria Quadrivalent | INFLUENZA A VIRUS A/Victoria/2570/2019 IVR-215 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Darwin/6/2021 IVR-227 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Austria/1359417/2021 BVR-26 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Phuket/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-418 | AFLURIA QUADRIVALENT | INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED), AND INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-419 | Afluria Quadrivalent | INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-420 | Afluria Quadrivalent | INFLUENZA A VIRUS A/VICTORIA/2454/2019 IVR-207 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-421 | Afluria Quadrivalent | INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/CAMBODIA/E0826360/2020 IVR-224 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-422 | Afluria Quadrivalent | INFLUENZA A VIRUS A/Victoria/2570/2019 IVR-215 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Darwin/6/2021 IVR-227 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Austria/1359417/2021 BVR-26 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Phuket/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
Trademark Results [AFLURIA QUADRIVALENT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AFLURIA QUADRIVALENT 87684481 5676287 Live/Registered |
CSL Limited 2017-11-14 |
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