HEPLISAV-B
- Product NDC
- 43528-003
- 11-digit product format
- 435280003
- Labeler code
- 43528
- Product ID
- 43528-003_4b308f87-c35b-9d96-e063-6294a90aff8e
- Type
- VACCINE
- Nonproprietary name
- Hepatitis B Vaccine (Recombinant) Adjuvanted
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Dynavax Technologies Corporation
- 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 |
|---|---|
| HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN | 20 ug/.5mL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43528-003-01 | HEPLISAV-B | 0.5 mL in 1 SYRINGE | INJECTION, SOLUTION | 0.5 | 10 | |
| 43528-003-05 | HEPLISAV-B | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43528-003-01 | ML - Milliliter | 43528-003 | c15dcb4a-a60d-4115-a840-884a227c2633 | 1 | 2018-08-13 |
| 43528-003-05 | ML - Milliliter | 43528-003 | c5c697f3-6361-4830-844a-05382fa0c562 | 1 | 2018-08-13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 43528-003 | HEPLISAV-B (HEPATITIS B VACCINE (RECOMBINANT) ADJUVANTED) INJECTION, SOLUTION [DYNAVAX TECHNOLOGIES CORPORATION] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240920_d61c7f99-438b-4cac-ae10-997ff4c0fd1f.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1994347 | hepatitis B surface antigen vaccine 20 MCG in 0.5 ML Injection | PSN | d61c7f99-438b-4cac-ae10-997ff4c0fd1f | 10 |
| 2050057 | hepatitis B surface antigen vaccine 20 MCG in 0.5 ML Prefilled Syringe | PSN | 618db7b8-a5e4-49c8-9390-38912e6f39fd | 10 |
| 2050057 | hepatitis B surface antigen vaccine 20 MCG in 0.5 ML Prefilled Syringe | PSN | d61c7f99-438b-4cac-ae10-997ff4c0fd1f | 10 |
| 1994352 | HEPLISAV-B 20 MCG in 0.5 ML Injection | PSN | d61c7f99-438b-4cac-ae10-997ff4c0fd1f | 10 |
| 2050059 | HEPLISAV-B 20 MCG in 0.5 ML Prefilled Syringe | PSN | 618db7b8-a5e4-49c8-9390-38912e6f39fd | 10 |
| 2050059 | HEPLISAV-B 20 MCG in 0.5 ML Prefilled Syringe | PSN | d61c7f99-438b-4cac-ae10-997ff4c0fd1f | 10 |
| 1994352 | 0.5 ML hepatitis B surface antigen vaccine 0.04 MG/ML Injection [Heplisav-B] | SBD | d61c7f99-438b-4cac-ae10-997ff4c0fd1f | 10 |
| 2050059 | 0.5 ML hepatitis B surface antigen vaccine 0.04 MG/ML Prefilled Syringe [Heplisav-B] | SBD | 618db7b8-a5e4-49c8-9390-38912e6f39fd | 10 |
| 2050059 | 0.5 ML hepatitis B surface antigen vaccine 0.04 MG/ML Prefilled Syringe [Heplisav-B] | SBD | d61c7f99-438b-4cac-ae10-997ff4c0fd1f | 10 |
| 1994347 | 0.5 ML hepatitis B surface antigen vaccine 0.04 MG/ML Injection | SCD | d61c7f99-438b-4cac-ae10-997ff4c0fd1f | 10 |
| 2050057 | 0.5 ML hepatitis B surface antigen vaccine 0.04 MG/ML Prefilled Syringe | SCD | 618db7b8-a5e4-49c8-9390-38912e6f39fd | 10 |
| 2050057 | 0.5 ML hepatitis B surface antigen vaccine 0.04 MG/ML Prefilled Syringe | SCD | d61c7f99-438b-4cac-ae10-997ff4c0fd1f | 10 |
| 2050059 | 0.5 ML Heplisav-B 0.04 MG/ML Prefilled Syringe | SY | d61c7f99-438b-4cac-ae10-997ff4c0fd1f | 10 |
| 2050059 | 0.5 ML Heplisav-B 0.04 MG/ML Prefilled Syringe | SY | 618db7b8-a5e4-49c8-9390-38912e6f39fd | 10 |
| 1994347 | hepatitis B surface antigen vaccine 0.04 MG/ML per 0.5 ML Injection | SY | d61c7f99-438b-4cac-ae10-997ff4c0fd1f | 10 |
| 2050057 | hepatitis B surface antigen vaccine 0.04 MG/ML per 0.5 ML Prefilled Syringe | SY | d61c7f99-438b-4cac-ae10-997ff4c0fd1f | 10 |
| 2050057 | hepatitis B surface antigen vaccine 0.04 MG/ML per 0.5 ML Prefilled Syringe | SY | 618db7b8-a5e4-49c8-9390-38912e6f39fd | 10 |
| 1994347 | hepatitis B surface antigen vaccine 20 MCG per 0.5 ML Injection | SY | d61c7f99-438b-4cac-ae10-997ff4c0fd1f | 10 |
| 1994347 | hepatitis B vaccine (recombinant) pediatric/adolescent 20 MCG in 0.5 ML Injection | SY | d61c7f99-438b-4cac-ae10-997ff4c0fd1f | 10 |
| 1994352 | Heplisav-B 0.04 MG/ML per 0.5 ML Injection | SY | d61c7f99-438b-4cac-ae10-997ff4c0fd1f | 10 |
| 2050059 | Heplisav-B 0.04 MG/ML per 0.5 ML Prefilled Syringe | SY | d61c7f99-438b-4cac-ae10-997ff4c0fd1f | 10 |
| 2050059 | Heplisav-B 0.04 MG/ML per 0.5 ML Prefilled Syringe | SY | 618db7b8-a5e4-49c8-9390-38912e6f39fd | 10 |
| 1994352 | Heplisav-B 20 MCG per 0.5 ML Injection | SY | d61c7f99-438b-4cac-ae10-997ff4c0fd1f | 10 |
| 2050059 | HEPLISAV-B 20 MCG per 0.5 ML Prefilled Syringe | SY | d61c7f99-438b-4cac-ae10-997ff4c0fd1f | 10 |
| 2050059 | HEPLISAV-B 20 MCG per 0.5 ML Prefilled Syringe | SY | 618db7b8-a5e4-49c8-9390-38912e6f39fd | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43528-003-01 | 43528000301 | 0.5 mL in 1 SYRINGE | 0.5 ml | Historical | ||||
| 43528-003-05 | 43528000305 | 5 SYRINGE in 1 CARTON (43528-003-05) / .5 mL in 1 SYRINGE (43528-003-01) | 5 syringe | 2018-01-01 | 0000-00-00 | No | No | Current |