Shingrix
- Product NDC
- 58160-849
- 11-digit product format
- 581600849
- Labeler code
- 58160
- Product ID
- 58160-849_e8a2f0fb-062a-4adc-ac30-f378fbcf87ed
- Type
- VACCINE
- Nonproprietary name
- Zoster Vaccine Recombinant, Adjuvanted
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- GlaxoSmithKline Biologicals SA
- 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 |
|---|
| 58160-849-43 | Shingrix | 0.5 mL in 1 SYRINGE | INJECTION, SOLUTION | 0.5 | | 23 |
| 58160-849-52 | Shingrix | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 23 |
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#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1986830 | SHINGRIX vaccine 0.5 ML Injection | PSN | 0280849d-5c78-4a9d-8941-4eab429f6bd8 | 23 |
| 2719778 | SHINGRIX vaccine 0.5 ML Prefilled Syringe | PSN | 0280849d-5c78-4a9d-8941-4eab429f6bd8 | 23 |
| 1986825 | varicella zoster virus glycoprotein E vaccine recombinant 0.1 MG/mL Injection | PSN | 0280849d-5c78-4a9d-8941-4eab429f6bd8 | 23 |
| 2719774 | varicella zoster virus glycoprotein E, recombinant vaccine 0.5 ML Prefilled Syringe | PSN | 0280849d-5c78-4a9d-8941-4eab429f6bd8 | 23 |
| 1986830 | 0.5 ML varicella zoster virus glycoprotein E, recombinant 0.1 MG/ML Injection [Shingrix] | SBD | 0280849d-5c78-4a9d-8941-4eab429f6bd8 | 23 |
| 2719778 | 0.5 ML varicella zoster virus glycoprotein E, recombinant 0.1 MG/ML Prefilled Syringe [Shingrix] | SBD | 0280849d-5c78-4a9d-8941-4eab429f6bd8 | 23 |
| 1986825 | 0.5 ML varicella zoster virus glycoprotein E, recombinant 0.1 MG/ML Injection | SCD | 0280849d-5c78-4a9d-8941-4eab429f6bd8 | 23 |
| 2719774 | 0.5 ML varicella zoster virus glycoprotein E, recombinant 0.1 MG/ML Prefilled Syringe | SCD | 0280849d-5c78-4a9d-8941-4eab429f6bd8 | 23 |
| 1986830 | 0.5 ML Shingrix 0.1 MG/ML Injection | SY | 0280849d-5c78-4a9d-8941-4eab429f6bd8 | 23 |
| 2719778 | 0.5 ML Shingrix 0.1 MG/ML Prefilled Syringe | SY | 0280849d-5c78-4a9d-8941-4eab429f6bd8 | 23 |
| 1986825 | 0.5 ML zoster vaccine, recombinant 0.1 MG/ML | SY | 0280849d-5c78-4a9d-8941-4eab429f6bd8 | 23 |
| 1986830 | Shingrix vaccine 0.5 ML Injection | SY | 0280849d-5c78-4a9d-8941-4eab429f6bd8 | 23 |
| 2719778 | Shingrix vaccine 0.5 ML Prefilled Syringe | SY | 0280849d-5c78-4a9d-8941-4eab429f6bd8 | 23 |
| 2719774 | varicella zoster virus glycoprotein E, recombinant vaccine 0.5 ML Prefilled Syringe | SY | 0280849d-5c78-4a9d-8941-4eab429f6bd8 | 23 |
| 2719778 | SHINGRIX vaccine 0.5 ML Prefilled Syringe | PSN | c46e8702-5680-462b-a093-0c7720f77020 | 1 |
| 2719774 | varicella zoster virus glycoprotein E, recombinant vaccine 0.5 ML Prefilled Syringe | PSN | c46e8702-5680-462b-a093-0c7720f77020 | 1 |
| 2719778 | 0.5 ML varicella zoster virus glycoprotein E, recombinant 0.1 MG/ML Prefilled Syringe [Shingrix] | SBD | c46e8702-5680-462b-a093-0c7720f77020 | 1 |
| 2719774 | 0.5 ML varicella zoster virus glycoprotein E, recombinant 0.1 MG/ML Prefilled Syringe | SCD | c46e8702-5680-462b-a093-0c7720f77020 | 1 |
| 2719778 | 0.5 ML Shingrix 0.1 MG/ML Prefilled Syringe | SY | c46e8702-5680-462b-a093-0c7720f77020 | 1 |
| 2719778 | Shingrix vaccine 0.5 ML Prefilled Syringe | SY | c46e8702-5680-462b-a093-0c7720f77020 | 1 |
| 2719774 | varicella zoster virus glycoprotein E, recombinant vaccine 0.5 ML Prefilled Syringe | SY | c46e8702-5680-462b-a093-0c7720f77020 | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58160-849-43 | 58160084943 | 0.5 mL in 1 SYRINGE | 0.5 ml | | | | Historical |
| 58160-849-52 | 58160084952 | 10 SYRINGE in 1 CARTON (58160-849-52) / .5 mL in 1 SYRINGE (58160-849-43) | 10 syringe | 2025-07-16 | No | No | Current |