TWINRIX
- Product NDC
- 58160-815
- 11-digit product format
- 581600815
- Labeler code
- 58160
- Product ID
- 58160-815_f99d8a1b-e81c-4ccc-9a97-b47dc52039ad
- Type
- VACCINE
- Nonproprietary name
- Hepatitis A and Hepatitis B (Recombinant) Vaccine
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- GlaxoSmithKline Biologicals SA
- Application
- BLA103850
- Marketing category
- BLA
- Marketing start
- 2007-06-07
- Substance
- HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN
- Active strength
- 720; 20 [iU]/mL; ug/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
- TWINRIX
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) | 720 [iU]/mL |
| HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN | 20 ug/mL |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58160-815-43 | TWINRIX | 1 mL in 1 SYRINGE | INJECTION, SUSPENSION | 1 | | 34 |
| 58160-815-52 | TWINRIX | 10 in 1 CARTON | INJECTION, SUSPENSION | 10 | | 34 |
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 | TWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA] | 17 | |
| HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN | ACTIVE INGREDIENT | 9GCJ1L5D1P | TWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA] | 17 | |
| HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) | ACTIVE MOIETY | 5BFC8LZ6LQ | TWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA] | 17 | |
| HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN | ACTIVE MOIETY | 9GCJ1L5D1P | TWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA] | 17 | |
| ALUMINUM HYDROXIDE | INACTIVE INGREDIENT | 5QB0T2IUN0 | TWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA] | 17 | |
| ALUMINUM PHOSPHATE | INACTIVE INGREDIENT | F92V3S521O | TWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA] | 17 | |
| FORMALDEHYDE | INACTIVE INGREDIENT | 1HG84L3525 | TWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA] | 17 | |
| NEOMYCIN SULFATE | INACTIVE INGREDIENT | 057Y626693 | TWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA] | 17 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | TWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA] | 17 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | TWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA] | 17 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | TWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA] | 17 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58160-815 | TWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA] | 31 | Current NDC, Legacy NDC, 2 package rows | 20250426_18e8f9fc-4d62-4d30-4ab7-bac03336171e.zip |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 103850 | Twinrix | Hepatitis A & Hepatitis B (Recombinant) Vaccine | 351(a) | Rx | 2026-06-01 |
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 |
|---|
| 58160-815-43 | 58160081543 | 1 mL in 1 SYRINGE | 1 ml | | | | | Historical |
| 58160-815-52 | 58160081552 | 10 SYRINGE in 1 CARTON (58160-815-52) / 1 mL in 1 SYRINGE (58160-815-43) | 10 syringe | 2007-06-07 | 0000-00-00 | No | No | Current |