NDC 58160-825
HAVRIX
Hepatitis A Vaccine
HAVRIX is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Glaxosmithkline Biologicals Sa. The primary component is Hepatitis A Virus Strain Hm175 Antigen (formaldehyde Inactivated).
| Product ID | 58160-825_2e1feba0-92d3-4d43-974b-3e8a4ef71f00 |
| NDC | 58160-825 |
| Product Type | Vaccine |
| Proprietary Name | HAVRIX |
| Generic Name | Hepatitis A Vaccine |
| Dosage Form | Injection, Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2007-02-16 |
| Marketing Category | BLA / BLA |
| Application Number | BLA103475 |
| Labeler Name | GlaxoSmithKline Biologicals SA |
| Substance Name | HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) |
| Active Ingredient Strength | 720 [iU]/.5mL |
| Pharm Classes | Actively Acquired Immunity [PE], Hepatitis A Vaccines [CS], Inactivated Hepatitis A Virus Vaccine [EPC], Vaccines, Inactivated [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 58160-825-52
10 SYRINGE in 1 CARTON (58160-825-52) > .5 mL in 1 SYRINGE (58160-825-43)
| Marketing Start Date | 2007-02-16 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 58160-825-01 [58160082501]
HAVRIX INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103475 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2007-02-16 |
NDC 58160-825-11 [58160082511]
HAVRIX INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103475 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2007-02-16 |
NDC 58160-825-41 [58160082541]
HAVRIX INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103475 |
| Product Type | VACCINE |
| Marketing Start Date | 2007-02-16 |
| Marketing End Date | 2013-02-08 |
NDC 58160-825-43 [58160082543]
HAVRIX INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103475 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2010-08-03 |
NDC 58160-825-51 [58160082551]
HAVRIX INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103475 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2007-02-16 |
| Marketing End Date | 2013-02-08 |
NDC 58160-825-46 [58160082546]
HAVRIX INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103475 |
| Product Type | VACCINE |
| Marketing Start Date | 2007-02-16 |
| Marketing End Date | 2012-02-25 |
NDC 58160-825-52 [58160082552]
HAVRIX INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103475 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2010-08-03 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) | 720 [iU]/.5mL |
Pharmacological Class
- Inactivated Hepatitis A Virus Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Hepatitis A Vaccines [CS]
- Vaccines
- Inactivated [CS]
NDC Crossover Matching brand name "HAVRIX" or generic name "Hepatitis A Vaccine"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 50090-1502 | HAVRIX | Hepatitis A Vaccine |
| 55045-3841 | HAVRIX | Hepatitis A Vaccine |
| 58160-825 | HAVRIX | Hepatitis A Vaccine |
| 58160-826 | HAVRIX | Hepatitis A Vaccine |
| 68258-8912 | HAVRIX | Hepatitis A Vaccine |
Trademark Results [HAVRIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HAVRIX 74042847 1701341 Live/Registered |
SmithKline Biologicals, S.A. 1990-03-26 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.