HAVRIX
- Product NDC
- 58160-825
- 11-digit product format
- 581600825
- Labeler code
- 58160
- Product ID
- 58160-825_da1bf14f-4608-4053-ba84-1875481ba838
- Type
- VACCINE
- Nonproprietary name
- Hepatitis A Vaccine
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- GlaxoSmithKline Biologicals SA
- Application
- BLA103475
- Marketing category
- BLA
- Marketing start
- 2007-02-16
- Substance
- HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)
- Active strength
- 720 [iU]/.5mL
- Pharmacologic classes
- Actively Acquired Immunity [PE], Hepatitis A Vaccines [CS], Inactivated Hepatitis A 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
- HAVRIX
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) | 720 [iU]/.5mL |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58160-825-43 | HAVRIX | 0.5 mL in 1 SYRINGE | INJECTION, SUSPENSION | 0.5 | | 33 |
| 58160-825-52 | HAVRIX | 10 in 1 CARTON | INJECTION, SUSPENSION | 10 | | 33 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58160-825 | HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA] | 31 | Current NDC, Legacy NDC, 2 package rows | 20250221_f9499a4d-1288-4bd3-9d59-1d72092c38cd.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 798479 | HAVRIX adult vaccine 1440 UNT in 1 ML Prefilled Syringe | PSN | f9499a4d-1288-4bd3-9d59-1d72092c38cd | 33 |
| 798482 | HAVRIX pediatric/adolescent vaccine 720 UNT in 0.5 ML Prefilled Syringe | PSN | f9499a4d-1288-4bd3-9d59-1d72092c38cd | 33 |
| 798477 | hepatitis A vaccine adult (HepA) 1440 UNT in 1 ML Prefilled Syringe | PSN | f9499a4d-1288-4bd3-9d59-1d72092c38cd | 33 |
| 798481 | hepatitis A vaccine pediatric/adolescent (HepA) 720 UNT in 0.5 ML Prefilled Syringe | PSN | f9499a4d-1288-4bd3-9d59-1d72092c38cd | 33 |
| 798482 | 0.5 ML hepatitis A vaccine (inactivated) strain HM175 1440 UNT/ML Prefilled Syringe [Havrix] | SBD | f9499a4d-1288-4bd3-9d59-1d72092c38cd | 33 |
| 798479 | 1 ML hepatitis A vaccine (inactivated) strain HM175 1440 UNT/ML Prefilled Syringe [Havrix] | SBD | f9499a4d-1288-4bd3-9d59-1d72092c38cd | 33 |
| 798481 | 0.5 ML hepatitis A vaccine (inactivated) strain HM175 1440 UNT/ML Prefilled Syringe | SCD | f9499a4d-1288-4bd3-9d59-1d72092c38cd | 33 |
| 798477 | 1 ML hepatitis A vaccine (inactivated) strain HM175 1440 UNT/ML Prefilled Syringe | SCD | f9499a4d-1288-4bd3-9d59-1d72092c38cd | 33 |
| 798482 | Havrix 720 UNT per 0.5 ML Prefilled Syringe, 0.5 ML | SY | f9499a4d-1288-4bd3-9d59-1d72092c38cd | 33 |
| 798479 | Havrix, Hepatitis A Vaccine (Inactivated), (Adult Dose) 1 ML Prefilled Syringe | SY | f9499a4d-1288-4bd3-9d59-1d72092c38cd | 33 |
| 798482 | Havrix, Hepatitis A Vaccine (Inactivated), (Pediatric Dose) 0.5 ML Prefilled Syringe | SY | f9499a4d-1288-4bd3-9d59-1d72092c38cd | 33 |
| 798477 | hepatitis A vaccine (inactivated) strain HM175 1440 UNT per 1 ML Prefilled Syringe | SY | f9499a4d-1288-4bd3-9d59-1d72092c38cd | 33 |
| 798481 | hepatitis A vaccine (inactivated) strain HM175 720 UNT per 0.5 ML Prefilled Syringe | SY | f9499a4d-1288-4bd3-9d59-1d72092c38cd | 33 |
| 798482 | HAVRIX pediatric/adolescent vaccine 720 UNT in 0.5 ML Prefilled Syringe | PSN | 7df68090-7e98-4b01-9c29-0b941a1c307d | 13 |
| 798481 | hepatitis A vaccine pediatric/adolescent (HepA) 720 UNT in 0.5 ML Prefilled Syringe | PSN | 7df68090-7e98-4b01-9c29-0b941a1c307d | 13 |
| 798482 | 0.5 ML hepatitis A vaccine (inactivated) strain HM175 1440 UNT/ML Prefilled Syringe [Havrix] | SBD | 7df68090-7e98-4b01-9c29-0b941a1c307d | 13 |
| 798481 | 0.5 ML hepatitis A vaccine (inactivated) strain HM175 1440 UNT/ML Prefilled Syringe | SCD | 7df68090-7e98-4b01-9c29-0b941a1c307d | 13 |
| 798482 | Havrix 720 UNT per 0.5 ML Prefilled Syringe, 0.5 ML | SY | 7df68090-7e98-4b01-9c29-0b941a1c307d | 13 |
| 798482 | Havrix, Hepatitis A Vaccine (Inactivated), (Pediatric Dose) 0.5 ML Prefilled Syringe | SY | 7df68090-7e98-4b01-9c29-0b941a1c307d | 13 |
| 798481 | hepatitis A vaccine (inactivated) strain HM175 720 UNT per 0.5 ML Prefilled Syringe | SY | 7df68090-7e98-4b01-9c29-0b941a1c307d | 13 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58160-825-43 | 58160082543 | 0.5 mL in 1 SYRINGE | 0.5 ml | | | | | Historical |
| 58160-825-52 | 58160082552 | 10 SYRINGE in 1 CARTON (58160-825-52) / .5 mL in 1 SYRINGE (58160-825-43) | 10 syringe | 2007-02-16 | 0000-00-00 | No | No | Current |