Comirnaty
- Product NDC
- 0069-2631
- 11-digit product format
- 000692631
- Labeler code
- 0069
- Product ID
- 0069-2631_0248cf65-e619-47eb-b9e2-355f9e797563
- Type
- VACCINE
- Nonproprietary name
- COVID-19 Vaccine, mRNA
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Application
- BLA125742
- Marketing category
- BLA
- Marketing start
- 2026-08-27
- Substance
- BNT-162B2 OMICRON (XFG) MRNA
- Active strength
- .042 mg/.418mL
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Comirnaty
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BNT-162B2 OMICRON (XFG) MRNA | .042 mg/.418mL |
DailyMed Product Concepts#
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125742 | Comirnaty | COVID-19 Vaccine, mRNA | 351(a) | Disc | 2026-08-01 |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 2722614 | COMIRNATY 2025-2026 vaccine, 0.3 ML Injection, 5y to < 12y | PSN | 48c86164-de07-4041-b9dc-f2b5744714e5 | 20 |
| 2722605 | COMIRNATY 2025-2026 vaccine, 0.3 ML Prefilled Syringe, 12y+ | PSN | 48c86164-de07-4041-b9dc-f2b5744714e5 | 20 |
| 2722609 | SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-BNT162b2 OMICRON (LP.8.1) 0.3 ML Injection, 5y to < 12y | PSN | 48c86164-de07-4041-b9dc-f2b5744714e5 | 20 |
| 2722598 | SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-BNT162b2 OMICRON (LP.8.1) 0.3 ML Prefilled Syringe, 12y+ | PSN | 48c86164-de07-4041-b9dc-f2b5744714e5 | 20 |
| 2722614 | 0.3 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-BNT162b2 OMICRON (LP.8.1) 0.0333 MG/ML Injection [Comirnaty 2025-2026] | SBD | 48c86164-de07-4041-b9dc-f2b5744714e5 | 20 |
| 2722605 | 0.3 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-BNT162b2 OMICRON (LP.8.1) 0.1 MG/ML Prefilled Syringe [Comirnaty 2025-2026] | SBD | 48c86164-de07-4041-b9dc-f2b5744714e5 | 20 |
| 2722609 | 0.3 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-BNT162b2 OMICRON (LP.8.1) 0.0333 MG/ML Injection | SCD | 48c86164-de07-4041-b9dc-f2b5744714e5 | 20 |
| 2722598 | 0.3 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-BNT162b2 OMICRON (LP.8.1) 0.1 MG/ML Prefilled Syringe | SCD | 48c86164-de07-4041-b9dc-f2b5744714e5 | 20 |
| 2722614 | 0.3 ML Comirnaty 2025-2026 0.0333 MG/ML Injection | SY | 48c86164-de07-4041-b9dc-f2b5744714e5 | 20 |
| 2722605 | 0.3 ML Comirnaty 2025-2026 0.1 MG/ML Prefilled Syringe | SY | 48c86164-de07-4041-b9dc-f2b5744714e5 | 20 |
| 2722614 | Comirnaty 2025-2026 vaccine, 0.3 ML Injection, 5y to < 12y | SY | 48c86164-de07-4041-b9dc-f2b5744714e5 | 20 |
| 2722605 | Comirnaty 2025-2026 vaccine, 0.3 ML Prefilled Syringe, 12y+ | SY | 48c86164-de07-4041-b9dc-f2b5744714e5 | 20 |
| 2722609 | SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-BNT162b2 OMICRON (LP.8.1) 0.3 ML Injection, 5y to < 12y | SY | 48c86164-de07-4041-b9dc-f2b5744714e5 | 20 |
| 2722598 | SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-BNT162b2 OMICRON (LP.8.1) 0.3 ML Prefilled Syringe, 12y+ | SY | 48c86164-de07-4041-b9dc-f2b5744714e5 | 20 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Status |
|---|
| 0069-2631-10 | 00069263110 | 10 SYRINGE, GLASS in 1 CARTON (0069-2631-10) / .418 mL in 1 SYRINGE, GLASS (0069-2631-01) | 2026-08-27 | 0 | Current |