Prescription drug · ANDA
nelarabine NDC 81927-111
Nelarabine 5 mg/mL · Injection · Intravenous · Shorla Oncology Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81927-111-01 | 81927011101 | 1 VIAL, SINGLE-DOSE in 1 CARTON (81927-111-01) / 50 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 15, 2023 | |
| 81927-111-06 | 81927011106 | 6 VIAL, SINGLE-DOSE in 1 CARTON (81927-111-06) / 50 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 15, 2023 |
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)
- nelarabine
- Generic name (nonproprietary)
- nelarabine
- Active ingredients
- Nelarabine — 5 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Shorla Oncology Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214809
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 81927-111_f21b358e-9f41-4dc3-858f-b55f9a8af715SPL ID f21b358e-9f41-4dc3-858f-b55f9a8af715SPL set ID fc401b06-4e3b-413e-a854-3e031c433862RxCUI 603566, 2722411UNII 60158CV180UPC 0381927111018
- Pharmacologic class
- Nucleoside Metabolic Inhibitor
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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N481927011101followed by a unit qualifier and the quantityPackage 81927-0111-01. 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)
Nelarabine Injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. Nelarabine Injection is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214809
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| nelarabine | Nelarabine 5 mg/mL | InjectionIntravenous | Shorla Oncology Inc. | 81927-375 |