AS03
- Product NDC
- 58160-855
- Requested package NDC
- 58160-855-19
- 11-digit product format
- 581600855
- Labeler code
- 58160
- Product ID
- 58160-855_16e1450f-1b3b-4cc3-8b67-b0fb63dadfd2
- Type
- VACCINE
- Nonproprietary name
- AS03
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- GlaxoSmithKline Biologicals SA
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2020-11-10
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- AS03
- Listing expiration
- 2026-12-31
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58160-855-01 | AS03 | 2.5 mL in 1 VIAL | INJECTION, SOLUTION | 2.5 | | 3 |
| 58160-855-19 | AS03 | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58160-855 | AS03 INJECTION, SOLUTION [GLAXOSMITHKLINE BIOLOGICALS SA] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240210_f136b41b-56f3-43a9-9d6a-61b2afca5b4a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58160-855-19 | 58160085519 | 10 VIAL in 1 CARTON (58160-855-19) / 2.5 mL in 1 VIAL (58160-855-01) | 10 vial | 2020-11-10 | 0000-00-00 | No | No | Current |