Shingrix
- Product NDC
- 50090-7919
- 11-digit product format
- 500907919
- Labeler code
- 50090
- Product ID
- 50090-7919_3cc5ee17-3376-493a-8146-42df66edb945
- Type
- VACCINE
- Nonproprietary name
- Zoster Vaccine Recombinant, Adjuvanted
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- A-S Medication Solutions
- Application
- BLA125614
- Marketing category
- BLA
- Marketing start
- 2025-07-16
- Substance
- RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN
- Active strength
- 50 ug/.5mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Shingrix
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN | 50 ug/.5mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-7919-0 | Shingrix | 1 mL in 1 KIT | INJECTION, SOLUTION | 1 | | 1 |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125614 | Shingrix | Zoster Vaccine Recombinant, Adjuvanted | 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 | Sample | Exclude flag | Status |
|---|
| 50090-7919-0 | 50090791900 | 1 mL in 1 KIT (50090-7919-0) | 1 ml | 2025-07-16 | No | No | Current |