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Web Site Publication Date: February 12, 2020
Release Notes: This release does not include updates for Vaccine Information Statement (VIS) codes and maps. Release notes and files for VIS code updates are distributed in separate release cycles. General Note regarding this release: Codes with “Last Update” dates after January 6, 2020 reflect the changes and additions in this release and include the following code set updates:
- NDC Influenza Season Update: Sanofi Product FLUZONE High-Dose Quadrivalent was previously introduced and described for the influenza season 2019/2020. The correct influenza season for this product is 2020/2021. The NDC descriptions have been updated to reflect this correction. The notes for the associated CVX code 197 and the CDC Product have also been updated to reflect the correct starting season for this new product.
| Proprietary/Trade Name | UoS NDC Code | UoU NDC Code |
|---|
| FLUZONE High-Dose Quadrivalent | 49281-120-65 | 49281-120-88 |
- NDC Unit of Sale and Units of Use Codes Added: The following new NDCs have been added.
| Unit of Sale NDC | Unit of Use NDC | Manufacturer/Labeler | Proprietary/Trade Name | CVX Code | MVX Code |
|---|
| 49281-252-51 | 49281-246-58 | Sanofi Pasteur Inc. | IMOVAX RABIES | 175 | PMC |
| 49281-511-05 | 49281-544-58 | Sanofi Pasteur Inc. | PENTACEL | 120 | PMC |
| 49281-511-05 | 49281-561-01 | Sanofi Pasteur Inc. | PENTACEL | 120 | PMC |
- NDC GTIN Updates: The following 2D barcoded NDCs have been updated with current GTINs based on information received from Seqirus.
| Unit of Sale NDC | UoS GTIN | Unit of Use NDC | UoU GTIN | Proprietary/Trade Name |
|---|
| 33332-219-20 | 00333332219209 | 33332-219-21 | 00333332219216 | Afluria Quadrivalent |
| 33332-319-01 | 00333332319015 | 33332-319-02 | 00333332319022 | Afluria Quadrivalent |
| 33332-419-10 | 00333332419104 | 33332-419-11 | 00333332419111 | Afluria Quadrivalent |
| 70461-319-03 | 00370461319035 | 70461-319-04 | 00370461319042 | FLUCELVAX QUADRIVALENT |
| 70461-419-10 | 00370461419100 | 70461-419-11 | 00370461419117 | FLUCELVAX QUADRIVALENT |
- NDC Codes Retired: The following NDC codes have been retired from the FDA files received.
| Unit of Sale NDC | Unit of Use NDC | Manufacturer/Labeler | Proprietary/Trade Name |
|---|
| 0006-4837-02 | --- | Merck Sharp & Dohme Corp. | PNEUMOVAX 23 |
| 33332-018-01 | 33332-018-02 | Seqirus Pty Ltd | AFLURIA |
| 33332-118-10 | 33332-118-11 | Seqirus Pty Ltd | AFLURIA |
| 33332-318-01 | 33332-318-02 | Seqirus Pty Ltd | AFLURIA QUADRIVALENT |
| 43528-002-05 | 43528-002-01 | Dynavax Technologies Corporation | HEPLISAV-B |
| 49281-915-01 | 49281-915-58 | Sanofi Pasteur Inc. | YF-VAX |
| 49281-915-05 | 49281-915-68 | Sanofi Pasteur Inc. | YF-VAX |
| 50090-1693-9 | 50090-1693-0 | A-S Medication Solutions | IPOL |
| 50090-2883-0 | 50090-2883-9 | A-S Medication Solutions | INFANRIX |
| 50090-3096-0 | --- | A-S Medication Solutions | RabAvert |
| 50090-3469-0 | 50090-3469-9 | A-S Medication Solutions | HEPLISAV-B |
- NDC description corrections: Minor errors were found on the NDC descriptions for the following two NDC codes for Afluria Quadrivalent:
Unit of Use NDC 33332-419-11 and Unit of Sale NDC 33332-419-10
