Shingrix
- Product NDC
- 58160-823
- 11-digit product format
- 581600823
- Labeler code
- 58160
- Product ID
- 58160-823_e8a2f0fb-062a-4adc-ac30-f378fbcf87ed
- Type
- VACCINE
- Nonproprietary name
- Zoster Vaccine Recombinant, Adjuvanted
- Dosage form
- KIT
- Labeler
- GlaxoSmithKline Biologicals SA
- Application
- BLA125614
- Marketing category
- BLA
- Marketing start
- 2017-10-20
- 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
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58160-823-11 | Shingrix | 1 in 1 CARTON | KIT | 1 | | 23 |
| 58160-828-03 | Shingrix | 0.5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 50 ug in 0.5mL | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58160-823 | SHINGRIX (ZOSTER VACCINE RECOMBINANT, ADJUVANTED) KIT [GLAXOSMITHKLINE BIOLOGICALS SA] | 19 | Current NDC, Legacy NDC, 2 package rows | 20250327_0280849d-5c78-4a9d-8941-4eab429f6bd8.zip |
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 |
| 1986830 | SHINGRIX vaccine 0.5 ML Injection | PSN | 279a251c-f4d0-4c47-b999-7ef1a45ac0d0 | 6 |
| 1986825 | varicella zoster virus glycoprotein E vaccine recombinant 0.1 MG/mL Injection | PSN | 279a251c-f4d0-4c47-b999-7ef1a45ac0d0 | 6 |
| 1986830 | 0.5 ML varicella zoster virus glycoprotein E, recombinant 0.1 MG/ML Injection [Shingrix] | SBD | 279a251c-f4d0-4c47-b999-7ef1a45ac0d0 | 6 |
| 1986825 | 0.5 ML varicella zoster virus glycoprotein E, recombinant 0.1 MG/ML Injection | SCD | 279a251c-f4d0-4c47-b999-7ef1a45ac0d0 | 6 |
| 1986830 | 0.5 ML Shingrix 0.1 MG/ML Injection | SY | 279a251c-f4d0-4c47-b999-7ef1a45ac0d0 | 6 |
| 1986825 | 0.5 ML zoster vaccine, recombinant 0.1 MG/ML | SY | 279a251c-f4d0-4c47-b999-7ef1a45ac0d0 | 6 |
| 1986830 | Shingrix vaccine 0.5 ML Injection | SY | 279a251c-f4d0-4c47-b999-7ef1a45ac0d0 | 6 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58160-823-11 | 58160082311 | 1 KIT in 1 CARTON (58160-823-11) * .5 mL in 1 VIAL (58160-828-03) * .5 mL in 1 VIAL (58160-829-03) | 1 kit | 2017-10-20 | 0000-00-00 | No | No | Current |
| 58160-828-03 | 58160082803 | 0.5 mL in 1 VIAL | 0.5 ml | | | | | Historical |