NDC 33332-115
AFLURIA
Influenza A Virus A/california/7/2009 X-181 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/texas/50/2012 X-223 (h3n2) Antigen (propiolactone Inactivated), And Influenza B Virus B/massachusetts/2/2012 Bx-51b Antigen (propiolactone Inactivated)
AFLURIA is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Biocsl Pty Ltd.. The primary component is Influenza A Virus A/california/7/2009 X-181 (h1n1) Antigen (propiolactone Inactivated); Influenza A Virus A/south Australia/55/2014 Ivr-175 (h3n2) Antigen (propiolactone Inactivated); Influenza B Virus B/phuket/3073/2013 Antigen (propiolactone Inactivated).
| Product ID | 33332-115_91776d76-04ff-438a-84a8-08d54e161ae0 |
| NDC | 33332-115 |
| Product Type | Vaccine |
| Proprietary Name | AFLURIA |
| Generic Name | Influenza A Virus A/california/7/2009 X-181 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/texas/50/2012 X-223 (h3n2) Antigen (propiolactone Inactivated), And Influenza B Virus B/massachusetts/2/2012 Bx-51b Antigen (propiolactone Inactivated) |
| Dosage Form | Injection, Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2011-07-15 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125254 |
| Labeler Name | bioCSL Pty Ltd. |
| Substance Name | INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 IVR-175 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (PROPIOLACTONE INACTIVATED) |
| Active Ingredient Strength | 15 ug/.5mL; ug/.5mL; ug/.5mL |
| Pharm Classes | Inactivated Influenza A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Influenza Vaccines [CS] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
Packaging
NDC 33332-115-10
1 VIAL, MULTI-DOSE in 1 CARTON (33332-115-10) > 5 mL in 1 VIAL, MULTI-DOSE (33332-115-11)
| Marketing Start Date | 2011-07-15 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 33332-115-10 [33332011510]
AFLURIA INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA125254 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2011-07-15 |
| Marketing End Date | 2016-12-31 |
NDC 33332-115-11 [33332011511]
AFLURIA INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA125254 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2011-07-15 |
| Marketing End Date | 2016-12-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) | 15 ug/.5mL |
Pharmacological Class
- Inactivated Influenza A Virus Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Vaccines
- Inactivated [CS]
- Influenza Vaccines [CS]
NDC Crossover Matching brand name "AFLURIA" or generic name "Influenza A Virus A/california/7/2009 X-181 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/texas/50/2012 X-223 (h3n2) Antigen (propiolactone Inactivated), And Influenza B Virus B/massachusetts/2/2012 Bx-51b Antigen (propiolactone Inactivated)"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 33332-015 | AFLURIA | INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-018 | AFLURIA | 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) AND INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-115 | AFLURIA | INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-118 | AFLURIA | 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) AND INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED) |
Trademark Results [AFLURIA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AFLURIA 79004750 3057916 Live/Registered |
CSL Limited 2004-07-13 |
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