Arexvy
- Product NDC
- 58160-882
- 11-digit product format
- 581600882
- Labeler code
- 58160
- Product ID
- 58160-882_2522c052-d323-459d-b9fd-76de846bc127
- Type
- VACCINE
- Nonproprietary name
- Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted
- Dosage form
- KIT
- Labeler
- GlaxoSmithKline Biologicals SA
- Application
- BLA125775
- Marketing category
- BLA
- Marketing start
- 2026-04-30
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Arexvy
- 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 |
|---|
| 58160-719-03 | Arexvy | 0.5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 120 ug in 0.5mL | 10 |
| 58160-882-12 | Arexvy | 1 in 1 CARTON | KIT | 1 | | 10 |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125775 | Arexvy | Respiratory Syncytial Virus Vaccine, 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 |
|---|
| 58160-719-03 | 58160071903 | 0.5 mL in 1 VIAL | 0.5 ml | | | | Historical |
| 58160-882-12 | 58160088212 | 1 KIT in 1 CARTON (58160-882-12) * .5 mL in 1 VIAL (58160-719-03) * .5 mL in 1 SYRINGE (58160-749-07) | 1 kit | 2026-04-30 | No | No | Current |