RECOMBIVAX HB
- Product NDC
- 83703-086
- 11-digit product format
- 837030086
- Labeler code
- 83703
- Product ID
- 83703-086_4c4c32a1-19c6-7646-e063-6294a90a431e
- Type
- VACCINE
- Nonproprietary name
- Hepatitis B Vaccine (Recombinant)
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR; SUBCUTANEOUS
- Labeler
- Bamboo US BidCo LLC
- Application
- BLA101066
- Marketing category
- BLA
- Marketing start
- 2026-02-26
- Substance
- HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN
- Active strength
- 10 ug/mL
- 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
- RECOMBIVAX HB
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN | 10 ug/mL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83703-086-02 | RECOMBIVAX HB | 1 mL in 1 SYRINGE | INJECTION, SUSPENSION | 1 | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 830243 | hepatitis B vaccine (recombinant) adult (HepB) 10 MCG in 1 ML Prefilled Syringe | PSN | 4c4c3b6a-0522-51a3-e063-6394a90ac5ed | 1 |
| 830252 | hepatitis B vaccine (recombinant) pediatric/adolescent (HepB) 5 MCG/0.5 ML Prefilled Syringe | PSN | 4c4c3b6a-0522-51a3-e063-6394a90ac5ed | 1 |
| 830245 | RECOMBIVAX HB adult vaccine 1 ML Prefilled Syringe | PSN | 4c4c3b6a-0522-51a3-e063-6394a90ac5ed | 1 |
| 830253 | RECOMBIVAX HB pediatric/adolescent vaccine 0.5 ML Prefilled Syringe | PSN | 4c4c3b6a-0522-51a3-e063-6394a90ac5ed | 1 |
| 830253 | 0.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Prefilled Syringe [Recombivax] | SBD | 4c4c3b6a-0522-51a3-e063-6394a90ac5ed | 1 |
| 830245 | 1 ML hepatitis B surface antigen vaccine 0.01 MG/ML Prefilled Syringe [Recombivax] | SBD | 4c4c3b6a-0522-51a3-e063-6394a90ac5ed | 1 |
| 830252 | 0.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Prefilled Syringe | SCD | 4c4c3b6a-0522-51a3-e063-6394a90ac5ed | 1 |
| 830243 | 1 ML hepatitis B surface antigen vaccine 0.01 MG/ML Prefilled Syringe | SCD | 4c4c3b6a-0522-51a3-e063-6394a90ac5ed | 1 |
| 830253 | 0.5 ML Recombivax HB Pediatric/Adolescent 10 MCG/ML Prefilled Syringe | SY | 4c4c3b6a-0522-51a3-e063-6394a90ac5ed | 1 |
| 830253 | 0.5 ML Recombivax HB, hepatitis B vaccine (recombinant) Prefilled Syringe | SY | 4c4c3b6a-0522-51a3-e063-6394a90ac5ed | 1 |
| 830245 | 1 ML Recombivax HB, Hepatitis B vaccine (recombinant) adult formulation Prefilled Syringe | SY | 4c4c3b6a-0522-51a3-e063-6394a90ac5ed | 1 |
| 830252 | hepatitis B surface antigen vaccine 0.005 MG per 0.5 ML Prefilled Syringe | SY | 4c4c3b6a-0522-51a3-e063-6394a90ac5ed | 1 |
| 830243 | hepatitis B surface antigen vaccine 0.01 MG per 1 ML Prefilled Syringe | SY | 4c4c3b6a-0522-51a3-e063-6394a90ac5ed | 1 |
| 830243 | hepatitis B surface antigen vaccine 10 MCG per 1 ML Prefilled Syringe | SY | 4c4c3b6a-0522-51a3-e063-6394a90ac5ed | 1 |
| 830252 | hepatitis B surface antigen vaccine 5 MCG per 0.5 ML Prefilled Syringe | SY | 4c4c3b6a-0522-51a3-e063-6394a90ac5ed | 1 |
| 830253 | Recombivax HB 5 MCG per 0.5 ML Prefilled Syringe | SY | 4c4c3b6a-0522-51a3-e063-6394a90ac5ed | 1 |
| 830245 | Recombivax HB, Hepatitis B vaccine (recombinant) adult formulation 10 MCG per 1 ML Prefilled Syringe | SY | 4c4c3b6a-0522-51a3-e063-6394a90ac5ed | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83703-086-02 | 83703008602 | 1 mL in 1 SYRINGE (83703-086-02) | 1 ml | 2026-02-26 | No | No | Current |