Prescription drug · ANDA
Nelarabine NDC 70121-1743
Nelarabine 5 mg/mL · Injection · Intravenous · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70121-1743-1 | 7012117430170121174301 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70121-1743-1) / 50 mL in 1 VIAL, SINGLE-DOSEMarketed from Nov 18, 2025 | |
| 70121-1743-4 | 7012117430470121174304 | 6 VIAL, SINGLE-DOSE in 1 CARTON (70121-1743-4) / 50 mL in 1 VIAL, SINGLE-DOSEMarketed from Apr 10, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Amneal Pharmaceuticals LLCNDC labeler code 70121
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216346
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 70121-1743_0aa120d1-67cb-4be7-8884-d716d8b2b8abSPL ID 0aa120d1-67cb-4be7-8884-d716d8b2b8abSPL set ID 8d0e1b59-bd1e-4c6e-9a95-e8143ee076bfRxCUI 603566UNII 60158CV180UPC 0370121174318
- 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
N470121174301followed by a unit qualifier and the quantityPackage 70121-1743-01. 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 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.
About NDC 70121-1743
- What is NDC 70121-1743?
- 70121-1743 is the product NDC for Nelarabine, Nelarabine 5 mg/mL injection, listed with the FDA by Amneal Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nelarabine.
- What is the active ingredient?
- Nelarabine.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 70121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nelarabine?
- 13 other product NDCs are listed under this name. See all Nelarabine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nelarabine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| nelarabine | Nelarabine 5 mg/mL | InjectionIntravenous | Shorla Oncology Inc. | 81927-375 | 81927-0375-01 |
| Nelarabine | Nelarabine 5 mg/mL | InjectionIntravenous | XGen Pharmaceuticals DJB, Inc. | 39822-0650 | 39822-0650-0139822-0650-06 |
| Nelarabine | Nelarabine 5 mg/mL | InjectionIntravenous | Novadoz Pharmaceuticals LLC | 72205-154 | 72205-0154-0172205-0154-04 |
| Nelarabine | Nelarabine 5 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-259 | 25021-0259-5025021-0259-51 |
| Nelarabine | Nelarabine 5 mg/mL | InjectionIntravenous | Alembic Pharmaceuticals Limited | 46708-813 | 46708-0813-5046708-0813-63 |
| Nelarabine | Nelarabine 5 mg/mL | InjectionIntravenous | Alembic Pharmaceuticals Inc. | 62332-813 | 62332-0813-5062332-0813-63 |
| Nelarabine | Nelarabine 5 mg/mL | InjectionIntravenous | Gland Pharma Limited | 68083-233 | 68083-0233-06 |
| nelarabine | Nelarabine 5 mg/mL | InjectionIntravenous | Shorla Oncology Inc. | 81927-111 | 81927-0111-0181927-0111-06 |
| Nelarabine | Nelarabine 5 mg/mL | InjectionIntravenous | Meitheal Pharmaceuticals Inc | 71288-165 | 71288-0165-54 |
| Nelarabine | Nelarabine 5 mg/mL | InjectionIntravenous | Dr. Reddy's Laboratories, Inc. | 43598-142 | 43598-0142-0643598-0142-11 |