TWINRIX
- Product NDC
- 50090-1645
- 11-digit product format
- 500901645
- Labeler code
- 50090
- Product ID
- 50090-1645_608f8399-db16-4921-b0c8-153b81b1d568
- Type
- VACCINE
- Nonproprietary name
- Hepatitis A and Hepatitis B (Recombinant) Vaccine
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- A-S Medication Solutions
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TWINRIX
- Listing expiration
- 2026-12-31
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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-1645-0 | TWINRIX | 10 in 1 CARTON | INJECTION, SUSPENSION | 10 | | 19 |
| 50090-1645-9 | TWINRIX | 1 mL in 1 SYRINGE | INJECTION, SUSPENSION | 1 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-1645 | TWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS] | 19 | Current NDC, Legacy NDC, 2 package rows | 20231210_dad367dd-7cb8-4344-9920-8710149473d2.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 |
|---|
| 50090-1645-0 | 50090164500 | 10 SYRINGE in 1 CARTON (50090-1645-0) / 1 mL in 1 SYRINGE (50090-1645-9) | 10 syringe | 2007-06-07 | 0000-00-00 | No | No | Current |
| 50090-1645-9 | 50090164509 | 1 mL in 1 SYRINGE | 1 ml | | | | | Historical |