BAVENCIO
- Product NDC
- 44087-3535
- Requested package NDC
- 44087-3535-1
- 11-digit product format
- 440873535
- Labeler code
- 44087
- Product ID
- 44087-3535_1c740e75-10b0-48c1-a92f-c7b76f9950c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- avelumab
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- EMD Serono, Inc.
- Application
- BLA761049
- Marketing category
- BLA
- Marketing start
- 2017-03-23
- Substance
- AVELUMAB
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Antibodies, Monoclonal [CS], Programmed Death Ligand-1 Antagonists [MoA], Programmed Death Ligand-1 Blocker [EPC], Programmed Death Ligand-1-directed Antibody Interactions [MoA]
- NDC exclude flag
- No
- 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
- BAVENCIO
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AVELUMAB | 20 mg/mL |
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 |
|---|
| 44087-3535-1 | BAVENCIO | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 23 |
| 44087-3535-1 | BAVENCIO | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION, CONCENTRATE | 10 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 44087-3535 | BAVENCIO (AVELUMAB) INJECTION, SOLUTION, CONCENTRATE [EMD SERONO, INC.] | 22 | Current NDC, Legacy NDC, 2 package rows | 20250417_5cd725a1-2fa4-408a-a651-57a7b84b2118.zip |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761049 | Bavencio | avelumab | 351(a) | Rx | 2026-09-01 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 44087-3535-1 | 44087353501 | 1 VIAL, SINGLE-DOSE in 1 CARTON (44087-3535-1) / 10 mL in 1 VIAL, SINGLE-DOSE | 2017-03-23 | 0000-00-00 | No | No | Current |