Prescription drug · BLA
Blincyto (blinatumomab) NDC 55513-160
Kit · Amgen, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55513-160-01 | 55513016001 | 1 KIT in 1 PACKAGE (55513-160-01) * 3.088 mL in 1 VIAL (55513-150-01) * 10.6 mL in 1 VIAL (55513-155-01)Marketed from Dec 18, 2014 | |
| 55513-160-21 | 55513016021 | 1 KIT in 1 PACKAGE (55513-160-21) * 3.088 mL in 1 VIAL (55513-150-01) * 10.6 mL in 1 VIAL (55513-155-01)Marketed from Apr 30, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Blincyto
- Generic name (nonproprietary)
- blinatumomab
- Dosage form
- Kit
- Labeler
- Amgen, Inc
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125557
- Marketing start
- Listing expires
- Identifiers
- Product ID 55513-160_4a2c4b49-a991-4ac7-80b3-4b2f8f62de30SPL ID 4a2c4b49-a991-4ac7-80b3-4b2f8f62de30SPL set ID 38b482a8-960b-4591-9857-5031ecb830aaRxCUI 1597262, 1597267
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N455513016001followed by a unit qualifier and the quantityPackage 55513-0160-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with: CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. ( 1.1 ) Relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). ( 1.2 ) CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy. ( 1.3 ) 1.1 MRD-positive B-cell Precursor ALL BLINCYTO is indicated for the treatment of CD19-positive B-cell precursor acute…
Excerpt only. Read the full label for complete information.