PREHEVBRIO
- Product NDC
- 75052-001
- 11-digit product format
- 750520001
- Labeler code
- 75052
- Product ID
- 75052-001_f1126e8c-6fd9-2ec9-e053-2995a90a9c24
- Type
- VACCINE
- Nonproprietary name
- Hepatitis B Vaccine (Recombinant)
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- VBI Vaccines (Delaware) Inc.
- Application
- BLA125737
- Marketing category
- BLA
- Marketing start
- 2021-12-01
- Marketing end
- 0000-00-00
- Substance
- 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 strength
- 10 ug/mL; ug/mL; ug/mL
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75052-001-01 | PREHEVBRIO | 1 mL in 1 VIAL, GLASS | INJECTION, SUSPENSION | 1 | | 6 |
| 75052-001-10 | PREHEVBRIO | 10 in 1 CARTON | INJECTION, SUSPENSION | 10 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75052-001 | PREHEVBRIO (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [VBI VACCINES (DELAWARE) INC.] | 6 | Legacy NDC, 2 package rows | 20240224_36e9a878-d6c2-4808-9915-294f47b1fe3d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 75052-001-01 | 75052000101 | 1 mL in 1 VIAL, GLASS | 1 ml | | | | | Historical |
| 75052-001-10 | 75052000110 | 10 VIAL, GLASS in 1 CARTON (75052-001-10) > 1 mL in 1 VIAL, GLASS (75052-001-01) | | 2021-12-01 | 0000-00-00 | No | No | Current |