NDC 75052-001
PREHEVBRIO
Hepatitis B Vaccine (recombinant)
PREHEVBRIO is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Vbi Vaccines (delaware) Inc.. The primary component is Recombinant Hepatitis B Surface Antigen (isoform L /sci-b-vac); Recombinant Hepatitis B Surface Antigen (isoform M/sci-b-vac); Recombinant Hepatitis B Surface Antigen (isoform S/sci-b-vac).
| Product ID | 75052-001_f1126e8c-6fd9-2ec9-e053-2995a90a9c24 |
| NDC | 75052-001 |
| Product Type | Vaccine |
| Proprietary Name | PREHEVBRIO |
| Generic Name | Hepatitis B Vaccine (recombinant) |
| Dosage Form | Injection, Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2021-12-01 |
| Marketing Category | BLA / |
| Application Number | BLA125737 |
| Labeler Name | VBI Vaccines (Delaware) Inc. |
| Substance Name | RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM L /SCI-B-VAC); RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM M/SCI-B-VAC); RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM S/SCI-B-VAC) |
| Active Ingredient Strength | 10 ug/mL; ug/mL; ug/mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 75052-001-10
10 VIAL, GLASS in 1 CARTON (75052-001-10) > 1 mL in 1 VIAL, GLASS (75052-001-01)
| Marketing Start Date | 2021-12-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
Drug Details
NDC Crossover Matching brand name "PREHEVBRIO" or generic name "Hepatitis B Vaccine (recombinant)"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 50090-1223 | ENGERIX-B | Hepatitis B Vaccine (Recombinant) |
| 50090-1706 | ENGERIX-B | Hepatitis B Vaccine (Recombinant) |
| 58160-820 | ENGERIX-B | Hepatitis B Vaccine (Recombinant) |
| 58160-821 | ENGERIX-B | Hepatitis B Vaccine (Recombinant) |
| 0006-4093 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
| 0006-4094 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
| 0006-4981 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
| 0006-4992 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
| 0006-4995 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
| 50090-1716 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
| 50090-1719 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
| 50090-1849 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
Trademark Results [PREHEVBRIO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PREHEVBRIO 97171192 not registered Live/Pending |
SCIVAC LIMITED 2021-12-14 |
 PREHEVBRIO 97082144 not registered Live/Pending |
SCIVAC LIMITED 2021-10-19 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.