NDC 58160-821
ENGERIX-B
Hepatitis B Vaccine (recombinant)
ENGERIX-B is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Glaxosmithkline Biologicals Sa. The primary component is Hepatitis B Virus Subtype Adw2 Hbsag Surface Protein Antigen.
| Product ID | 58160-821_15267df3-c997-4e6a-95bd-049846838c23 |
| NDC | 58160-821 |
| Product Type | Vaccine |
| Proprietary Name | ENGERIX-B |
| Generic Name | Hepatitis B Vaccine (recombinant) |
| Dosage Form | Injection, Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2007-03-28 |
| Marketing Category | BLA / BLA |
| Application Number | BLA103239 |
| Labeler Name | GlaxoSmithKline Biologicals SA |
| Substance Name | HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN |
| Active Ingredient Strength | 20 ug/mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 58160-821-11
10 VIAL in 1 CARTON (58160-821-11) > 1 mL in 1 VIAL (58160-821-01)
| Marketing Start Date | 2007-03-28 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 58160-821-32 [58160082132]
ENGERIX-B INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103239 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2009-11-16 |
| Marketing End Date | 2013-07-31 |
NDC 58160-821-34 [58160082134]
ENGERIX-B INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103239 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-09 |
NDC 58160-821-48 [58160082148]
ENGERIX-B INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103239 |
| Product Type | VACCINE |
| Marketing Start Date | 2010-08-03 |
| Marketing End Date | 2013-07-31 |
NDC 58160-821-11 [58160082111]
ENGERIX-B INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103239 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2007-03-28 |
NDC 58160-821-43 [58160082143]
ENGERIX-B INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103239 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2010-08-03 |
NDC 58160-821-52 [58160082152]
ENGERIX-B INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103239 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2011-01-06 |
NDC 58160-821-31 [58160082131]
ENGERIX-B INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103239 |
| Product Type | VACCINE |
| Marketing Start Date | 2007-03-28 |
| Marketing End Date | 2013-07-31 |
NDC 58160-821-46 [58160082146]
ENGERIX-B INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103239 |
| Product Type | VACCINE |
| Marketing Start Date | 2007-03-28 |
| Marketing End Date | 2013-07-31 |
NDC 58160-821-05 [58160082105]
ENGERIX-B INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103239 |
| Product Type | VACCINE |
| Marketing Start Date | 2012-03-09 |
NDC 58160-821-01 [58160082101]
ENGERIX-B INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103239 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2007-03-28 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN | 20 ug/mL |
NDC Crossover Matching brand name "ENGERIX-B" or generic name "Hepatitis B Vaccine (recombinant)"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 50090-1223 | ENGERIX-B | Hepatitis B Vaccine (Recombinant) |
| 50090-1706 | ENGERIX-B | Hepatitis B Vaccine (Recombinant) |
| 58160-820 | ENGERIX-B | Hepatitis B Vaccine (Recombinant) |
| 58160-821 | ENGERIX-B | Hepatitis B Vaccine (Recombinant) |
| 68258-3042 | ENGERIX-B | ENGERIX-B |
| 0006-4093 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
| 0006-4094 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
| 0006-4981 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
| 0006-4992 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
| 0006-4995 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
| 50090-1716 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
| 50090-1719 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
| 50090-1849 | RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) |
Trademark Results [ENGERIX-B]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENGERIX-B 76050783 2832321 Live/Registered |
GLAXOSMITHKLINE BIOLOGICALS S.A. 2000-05-17 |
 ENGERIX-B 76050489 2451009 Live/Registered |
GLAXOSMITHKLINE BIOLOGICALS S.A. 2000-05-17 |
 ENGERIX-B 75022211 2019144 Live/Registered |
GLAXOSMITHKLINE BIOLOGICALS S.A 1995-11-16 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.