HEPLISAV-B
- Product NDC
- 50090-4526
- 11-digit product format
- 500904526
- Labeler code
- 50090
- Product ID
- 50090-4526_bc19aced-d2fa-4b4f-8824-e15a56fe422d
- Type
- VACCINE
- Nonproprietary name
- Hepatitis B Vaccine (Recombinant) Adjuvanted
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- A-S Medication Solutions
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HEPLISAV-B
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN | 20 ug/.5mL |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-4526-0 | HEPLISAV-B | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 10 |
| 50090-4526-1 | HEPLISAV-B | .5 mL in 1 SYRINGE | INJECTION, SOLUTION | .5 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-4526 | HEPLISAV-B (HEPATITIS B VACCINE (RECOMBINANT) ADJUVANTED) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] | 10 | Current NDC, 2 package rows | 20250418_618db7b8-a5e4-49c8-9390-38912e6f39fd.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 |
|---|
| 50090-4526-0 | 50090452600 | 5 SYRINGE in 1 CARTON (50090-4526-0) / .5 mL in 1 SYRINGE (50090-4526-1) | 5 syringe | 2018-01-01 | No | No | Historical |
| 50090-4526-1 | 50090452601 | .5 mL in 1 SYRINGE | | | | | Historical |