HEPLISAV-B
- Product NDC
- 83703-048
- 11-digit product format
- 837030048
- Labeler code
- 83703
- Product ID
- 83703-048_49dccf66-c7fd-0ce9-e063-6394a90a3cf1
- Type
- VACCINE
- Nonproprietary name
- Hepatitis B Vaccine (Recombinant) Adjuvanted
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Bamboo US BidCo LLC
- Application
- BLA125428
- Marketing category
- BLA
- Marketing start
- 2018-01-01
- Substance
- HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN
- Active strength
- 20 ug/.5mL
- Pharmacologic classes
- Actively Acquired Immunity [PE], Hepatitis B Vaccines [CS], Inactivated Hepatitis B Virus Vaccine [EPC], Vaccines, Inactivated [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HEPLISAV-B
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN | 20 ug/.5mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83703-048-01 | HEPLISAV-B | 0.5 mL in 1 SYRINGE | INJECTION, SOLUTION | 0.5 | | 5 |
| 83703-048-05 | HEPLISAV-B | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83703-048 | HEPLISAV-B (HEPATITIS B VACCINE (RECOMBINANT) ADJUVANTED) INJECTION, SOLUTION [BAMBOO US BIDCO LLC] | 2 | Current NDC, 2 package rows | 20240618_1a8b8271-208d-ecde-e063-6294a90a54c6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83703-048-01 | 83703004801 | 0.5 mL in 1 SYRINGE | 0.5 ml | | | | Historical |
| 83703-048-05 | 83703004805 | 5 SYRINGE in 1 CARTON (83703-048-05) / .5 mL in 1 SYRINGE (83703-048-01) | 5 syringe | 2018-01-01 | No | No | Current |