HEPLISAV-B
- Product NDC
- 43528-002
- 11-digit product format
- 435280002
- Labeler code
- 43528
- Product ID
- 43528-002_cf21c709-2864-4ded-9b5f-b41f1f0f8f0b
- 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
- Marketing end
- 0000-00-00
- Substance
- HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN
- Active strength
- 20 ug/.5mL
- Pharmacologic classes
- Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [CS],Vaccines, Inactivated [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43528-002-01 | HEPLISAV-B | 0.5 mL in 1 VIAL | INJECTION, SOLUTION | 0.5 | 10 | |
| 43528-002-05 | 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 |
|---|---|---|---|---|---|
| 43528-002-01 | ML - Milliliter | 43528-002 | 67cb7ef6-ac0f-42e4-8cf4-bdf28a0ebad9 | 1 | 2018-02-20 |
| 43528-002-05 | ML - Milliliter | 43528-002 | 607bbbe9-9729-4566-b8d8-50a1a70a27ec | 1 | 2018-02-20 |
DailyMed Dashboard NDC Coverage#
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 | 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 | 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 | 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 | 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 |
| 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 |
| 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 |
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 43528-002-01 | 43528000201 | 0.5 mL in 1 VIAL | 0.5 ml | Historical |
| 43528-002-05 | 43528000205 | 5 in 1 CARTON | Historical |