HAVRIX
- Product NDC
- 58160-826
- 11-digit product format
- 581600826
- Labeler code
- 58160
- Product ID
- 58160-826_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
- 2007-04-13
- Substance
- HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)
- Active strength
- 1440 [iU]/mL
- 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) | 1440 [iU]/mL |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58160-826-43 | HAVRIX | 1 mL in 1 SYRINGE | INJECTION, SUSPENSION | 1 | | 33 |
| 58160-826-52 | HAVRIX | 10 in 1 CARTON | INJECTION, SUSPENSION | 10 | | 33 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) | ACTIVE INGREDIENT | 5BFC8LZ6LQ | HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA] | 18 | |
| HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) | ACTIVE MOIETY | 5BFC8LZ6LQ | HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA] | 18 | |
| ALUMINUM HYDROXIDE | INACTIVE INGREDIENT | 5QB0T2IUN0 | HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA] | 18 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA] | 18 | |
| HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) | ACTIVE INGREDIENT | 5BFC8LZ6LQ | HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
| HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) | ACTIVE INGREDIENT | 5BFC8LZ6LQ | HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
| HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) | ACTIVE MOIETY | 5BFC8LZ6LQ | HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
| HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) | ACTIVE MOIETY | 5BFC8LZ6LQ | HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
| ALUMINUM HYDROXIDE | INACTIVE INGREDIENT | 5QB0T2IUN0 | HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
| ALUMINUM HYDROXIDE | INACTIVE INGREDIENT | 5QB0T2IUN0 | HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58160-826 | 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#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58160-826-43 | 58160082643 | 1 mL in 1 SYRINGE | 1 ml | | | | | Historical |
| 58160-826-52 | 58160082652 | 10 SYRINGE in 1 CARTON (58160-826-52) / 1 mL in 1 SYRINGE (58160-826-43) | 10 syringe | 2007-04-13 | 0000-00-00 | No | No | Current |